Systems and methods for ablating tissue

ABSTRACT

Intra-cardiac voltage data display systems display a plurality of data sets derived at least from intra-cardiac voltage data sampled by an electrode. In some embodiments, at least some of the data sets are derived from a portion of the intra-cardiac voltage data that excludes an excludable portion of the intra-cardiac voltage data having a relationship with an occurrence of a particular cardiac event to facilitate identification of the existence of a transmural lesion in tissue adjacent the electrode. In some embodiments, the particular cardiac event is the occurrence of an R wave in the cardiac cycle, and the excludable portion is a V wave in the cardiac cycle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/411,546, filed May 14, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/499,193, filed Apr. 27, 2017, now U.S. Pat. No.10,327,844, issued Jun. 25, 2019, which is a continuation of

International Application No. PCT/US2014/063058, filed Oct. 30, 2014,wherein the entire disclosure of each of these applications is herebyincorporated herein by reference.

TECHNICAL FIELD

Aspects of this disclosure generally are related to systems and methodsfor activating transducers to ablate tissue and providing informationrelated to the tissue ablation.

BACKGROUND

Cardiac surgery was initially undertaken using highly invasive openprocedures. A sternotomy, which is a type of incision in the center ofthe chest that separates the sternum was typically employed to allowaccess to the heart. In the past several decades, more and more cardiacoperations are performed using intravascular or percutaneous techniques,where access to inner organs or other tissue is gained via a catheter.

Intravascular or percutaneous surgeries benefit patients by reducingsurgery risk, complications and recovery time. However, the use ofintravascular or percutaneous technologies also raises some particularchallenges. Medical devices used in intravascular or percutaneoussurgery need to be deployed via catheter systems which significantlyincrease the complexity of the device structure. As well, doctors do nothave direct visual contact with the medical devices once the devices arepositioned within the body.

One example of where intravascular or percutaneous medical techniqueshave been employed is in the treatment of a heart disorder called atrialfibrillation. Atrial fibrillation is a disorder in which spuriouselectrical signals cause an irregular heartbeat. Atrial fibrillation hasbeen treated with open heart methods using a technique known as the“Cox-Maze procedure”. During this procedure, physicians create specificpatterns of lesions in the left or right atria to block various pathstaken by the spurious electrical signals. Such lesions were originallycreated using incisions, but are now typically created by ablating thetissue with various techniques including radio-frequency (RF) energy,microwave energy, laser energy, and cryogenic techniques. The procedureis performed with a high success rate under the direct vision that isprovided in open procedures, but is relatively complex to performintravascularly or percutaneously because of the difficulty in creatinglesions with the desired characteristics.

Various problems may occur if the lesions are incorrectly formed. Forexample, unless the formed lesions are transmural (e.g., extend fullythroughout a thickness of the target cardiac tissue), their ability toblock paths taken within the heart by spurious electrical signals may becompromised. In some cases, increased levels of ablative energy,increased delivery times of the ablative energy, or both may allow forlesion transmurality to be achieved in the target cardiac tissue.However, since tissue thickness is variable and may not be easily orreadily ascertained in percutaneous procedures, various tissuestructures that underlie the target cardiac tissue, but which should notbe ablated, may be at risk of being subjected to the ablation energysupplied with increased levels or longer durations. One particularundesired complication that may arise is the formation ofatrio-esophageal fistulas.

In this regard, there is a need for improved intra-bodily-cavitytransducer-based device systems or control mechanisms thereof that canprovide improved indications of lesion transmurality, especially duringthe formation of the lesion.

SUMMARY

At least the above-discussed need is addressed and technical solutionsare achieved by various embodiments of the present invention. In someembodiments, device systems and methods executed by such systems exhibitenhanced capabilities for the control of ablation activation of varioustransducers, which may be located within a bodily cavity, such as anintra-cardiac cavity. In some embodiments, the systems or a portionthereof may be percutaneously or intravascularly delivered to positionthe various transducers within the bodily cavity. Various ones of thetransducers may be activated to distinguish tissue from blood and may beused to deliver positional information of the device relative to variousanatomical features in the bodily cavity, such as the pulmonary veinsand mitral valve in an atrium. Various ones of the transducers mayemploy characteristics such as blood flow detection, impedance changedetection or deflection force detection to discriminate between bloodand tissue. Various ones of the transducers may be used to treat tissuewithin a bodily cavity. Various ones of the transducers may be used todetect electrophysiological activity in the bodily cavity. Otheradvantages will become apparent from the teaching herein to those ofskill in the art.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The program may include data receptioninstructions configured to cause reception of intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time including a plurality ofcardiac cycles. The program may include cardiac event identificationinstructions configured to identify a respective occurrence of aparticular cardiac event in each of the plurality of cardiac cycles. Theprogram may include data identification instructions configured toidentify, for each respective one of the plurality of cardiac cycles, arespective first portion of the intra-cardiac voltage data sampledduring the respective one of the plurality of cardiac cycles, eachrespective first portion of the intra-cardiac voltage data identified inaccordance with a predetermined temporal relationship with therespective occurrence of the particular cardiac event identified in therespective one of the plurality of cardiac cycles. The program mayinclude excludable data identification instructions configured toidentify, for each respective one of the plurality of cardiac cycles, aparticular portion of the intra-cardiac voltage data sampled during therespective one of the plurality of cardiac cycles as an excludableportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles, eachidentified excludable portion of the intra-cardiac voltage dataincluding some but not all of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles. The program may include data derivation instructions configuredto derive, for each respective one of the plurality of cardiac cycles, arespective one of a plurality of data sets at least in part from arespective second portion of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles, each respective one of the plurality of data sets derived onlyfrom particular data that excludes the identified excludable portion ofthe intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. The program mayinclude display instructions configured to cause the input-output devicesystem to concurrently display the plurality of data sets.

In some embodiments, the excludable data identification instructions maybe configured to identify each excludable portion of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles as including the identified respective firstportion of the intra-cardiac voltage data sampled during the respectiveone of the plurality of cardiac cycles. In some embodiments, the dataidentification instructions may be configured to identify eachrespective first portion of the intra-cardiac voltage data as includinga portion of the intra-cardiac voltage data sampled by the electrode atleast in part during the occurrence of the particular cardiac eventidentified in the respective one of the plurality of cardiac cycles. Insome embodiments, the data identification instructions may be configuredto identify each respective first portion of the intra-cardiac voltagedata as including a portion of the intra-cardiac voltage data sampled bythe electrode at least in part during the respective one of theplurality of cardiac cycles after the occurrence of the particularcardiac event identified in the respective one of the plurality ofcardiac cycles. In some embodiments, the data identificationinstructions may be configured to identify each respective first portionof the intra-cardiac voltage data as including a portion of theintra-cardiac voltage data sampled by the electrode at least in partduring the respective one of the plurality of cardiac cycles before theoccurrence of the particular cardiac event identified in the respectiveone of the plurality of cardiac cycles. In some embodiments, the dataidentification instructions may be configured to identify eachrespective first portion of the intra-cardiac voltage data as includinga portion of the intra-cardiac voltage data sampled by the electrodeduring a predetermined time interval that includes the occurrence of theparticular cardiac event identified in the respective one of theplurality of cardiac cycles.

In some embodiments, the cardiac event identification instructions maybe configured to identify the respective occurrence of the particularcardiac event in each respective one of the plurality of cardiac cyclesfrom data other than the intra-cardiac voltage data sampled by theelectrode. In some embodiments, the cardiac event identificationinstructions may be configured to identify the respective occurrence ofthe particular cardiac event in each respective one of the plurality ofcardiac cycles from electrocardiogram data. In some embodiments, thecardiac event identification instructions may be configured to identifythe respective occurrence of the particular cardiac event in eachrespective one of the plurality of cardiac cycles as including a maximumabsolute voltage value in the electrocardiogram data in the respectiveone of the plurality of cardiac cycles. In some embodiments, the cardiacevent identification instructions may be configured to identify therespective occurrence of the particular cardiac event in each respectiveone of the plurality of cardiac cycles as a respective occurrence of anR wave in the electrocardiogram data during the respective one of theplurality of cardiac cycles. In some embodiments, the cardiac eventidentification instructions may be configured to identify the respectiveoccurrence of the particular cardiac event in each respective one of theplurality of cardiac cycles as a respective occurrence of at least partof a QRS complex in the electrocardiogram data during the respective oneof the plurality of cardiac cycles, a respective occurrence of a P wavein the electrocardiogram data during the respective one of the pluralityof cardiac cycles, or a respective occurrence of a T wave in theelectrocardiogram data during the respective one of the plurality ofcardiac cycles.

In some embodiments, the cardiac event identification instructions maybe configured to identify the respective occurrence of the particularcardiac event in each respective one of the plurality of cardiac cyclesas a respective occurrence of ventricular systole during the respectiveone of the plurality of cardiac cycles. In some embodiments, the cardiacevent identification instructions may be configured to identify therespective occurrence of the particular cardiac event in each respectiveone of the plurality of cardiac cycles as a respective occurrence ofventricular systole during the respective one of the plurality ofcardiac cycles, a respective occurrence of ventricular diastole duringthe respective one of the plurality of cardiac cycles, a respectiveoccurrence of atrial systole during the respective one of the pluralityof cardiac cycles, or a respective occurrence of atrial diastole duringthe respective one of the plurality of cardiac cycles.

In some embodiments, the cardiac event identification instructions maybe configured to identify the respective occurrence of the particularcardiac event in each respective one of the plurality of cardiac cyclesfrom the intra-cardiac voltage data sampled by the electrode. In someembodiments, the cardiac event identification instructions may beconfigured to identify the respective occurrence of the particularcardiac event in each respective one of the plurality of cardiac cyclesat least from intra-cardiac electrogram data derived from intra-cardiacvoltage data other than the intra-cardiac voltage data sampled by theelectrode. In some embodiments, the cardiac event identificationinstructions may be configured to identify the respective occurrence ofthe particular cardiac event in each respective one of the plurality ofcardiac cycles as a respective occurrence of a V wave in theintra-cardiac electrogram data, the V wave occurring during therespective one of the plurality of cardiac cycles.

In some embodiments, the data derivation instructions may be configuredto derive each respective one of the plurality of data sets at least inpart from a first respective part of the respective second portion ofthe intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, the first respectivepart including a maximum value as compared with other parts of therespective second portion of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles. In some embodiments, the data derivation instructions may beconfigured to derive each respective one of the plurality of data setsat least in part from a second respective part of the respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles, the secondrespective part including a minimum value as compared with other partsof the respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles.

In some embodiments, each of the plurality of data sets may include datarepresentative of a maximum absolute value in the respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles. In someembodiments, each of the plurality of data sets may include datarepresentative of a difference between a maximum value and a minimumvalue in the respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles. In some embodiments, each of the plurality of data setsmay include data representative of a difference between two values inthe respective second portion of the intra-cardiac voltage data sampledby the electrode during the respective one of the plurality of cardiaccycles.

In some embodiments, the program may include activation instructionsconfigured to cause the electrode to transmit energy sufficient to causetissue ablation at least during the sampling of the intra-cardiacvoltage data by the electrode over the period of time including theplurality of cardiac cycles.

In some embodiments, the display instructions may be configured to causethe input-output device system to sequentially display each of theplurality of data sets until all of the plurality of data sets areconcurrently displayed by the input-output device system. In someembodiments, the display instructions may be configured to cause theinput-output device system to sequentially display each of the pluralityof data sets according to a first order that is consistent with an orderof the plurality of cardiac cycles during the period of time. In someembodiments, the display instructions may be configured to cause theinput-output device system to display the plurality of the data sets ina first spatial order representative of an order of the plurality ofcardiac cycles during the period of time. In some embodiments, thedisplay instructions may be configured to cause the input-output devicesystem to sequentially display each of the plurality of data setsaccording to a first order that is consistent with the order of theplurality of cardiac cycles during the period of time. In someembodiments, the display instructions may be configured to cause theinput-output device system to display an intra-cardiac electrogramconcurrently with the plurality of data sets, the intra-cardiacelectrogram derived from at least a portion of the intra-cardiac voltagedata sampled by the electrode, and the intra-cardiac electrogramundergoing a biphasic to monophasic transformation during at least partof the sequential display of each of the plurality of data sets. In someembodiments, the display instructions may be configured to cause theinput-output device system to display a monophasic intra-cardiacelectrogram concurrently with the plurality of data sets, the monophasicintra-cardiac electrogram derived from at least a portion of theintra-cardiac voltage data sampled by the electrode, and the monophasicintra-cardiac electrogram reducing in amplitude with each sequentialdisplay of each of at least some of the plurality of data sets. In someembodiments, the monophasic intra-cardiac electrogram has a positivepolarity.

In some embodiments, the display instructions may be configured to causethe input-output device system to display an intra-cardiac electrogramconcurrently with the plurality of data sets, the intra-cardiacelectrogram derived from at least a portion of the intra-cardiac voltagedata sampled by the electrode. The intra-cardiac electrogram may amonophasic intra-cardiac electrogram. The monophasic intra-cardiacelectrogram may have a positive polarity in some embodiments. In someembodiments, the display instructions may be configured to cause theinput-output device system to display the plurality of data sets amongat least a portion of the intra-cardiac electrogram.

In some embodiments, each of the plurality of data sets may include arespective one of a plurality of voltage magnitude sets. Each respectiveone of the plurality of voltage magnitude sets may befrequency-weighted. In some embodiments, each respective second portionof the intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles may includefrequency-weighted data. In some embodiments, the intra-cardiac voltagedata may be sampled by the electrode while positioned at a same locationin an intra-cardiac cavity during each of the plurality of cardiaccycles in the period of time.

Various systems may include combinations and subsets of all the systemssummarized above or otherwise described herein.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The data processing device system may beconfigured by the program at least to receive intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time including a plurality ofcardiac cycles. The data processing device system may be configured bythe program at least to identify a respective occurrence of a particularcardiac event in each of the plurality of cardiac cycles. The dataprocessing device system may be configured by the program at least toidentify, for each respective one of the plurality of cardiac cycles, arespective first portion of the intra-cardiac voltage data sampledduring the respective one of the plurality of cardiac cycles, eachrespective first portion of the intra-cardiac voltage data identified inaccordance with a predetermined temporal relationship with therespective occurrence of the particular cardiac event identified in therespective one of the plurality of cardiac cycles. The data processingdevice system may be configured by the program at least to identify, foreach respective one of the plurality of cardiac cycles, a particularportion of the intra-cardiac voltage data sampled during the respectiveone of the plurality of cardiac cycles as an excludable portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each identifiedexcludable portion of the intra-cardiac voltage data including some butnot all of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles. The dataprocessing device system may be configured by the program at least toderive, for each respective one of the plurality of cardiac cycles, arespective one of a plurality of data sets at least in part from arespective second portion of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles, each respective one of the plurality of data sets derived onlyfrom particular data that excludes the identified excludable portion ofthe intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. The data processingdevice system may be configured by the program at least to cause theinput-output device system to concurrently display the plurality of datasets.

In some embodiments, an intra-cardiac voltage data display method isexecuted by a data processing device system according to a programstored by a memory device system communicatively connected to the dataprocessing device system, the data processing device system furthercommunicatively connected to an input-output device system. The methodmay include receiving intra-cardiac voltage data via the input-outputdevice system, the intra-cardiac voltage data sampled by an electrodeover a period of time including a plurality of cardiac cycles. Themethod may include identifying a respective occurrence of a particularcardiac event in each of the plurality of cardiac cycles. The method mayinclude identifying, for each respective one of the plurality of cardiaccycles, a respective first portion of the intra-cardiac voltage datasampled during the respective one of the plurality of cardiac cycles,each respective first portion of the intra-cardiac voltage dataidentified in accordance with a predetermined temporal relationship withthe respective occurrence of the particular cardiac event identified inthe respective one of the plurality of cardiac cycles. The method mayinclude identifying, for each respective one of the plurality of cardiaccycles, a particular portion of the intra-cardiac voltage data sampledduring the respective one of the plurality of cardiac cycles as anexcludable portion of the intra-cardiac voltage data sampled by theelectrode during the respective one of the plurality of cardiac cycles,each identified excludable portion of the intra-cardiac voltage dataincluding some but not all of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles. The method may include deriving, for each respective one of theplurality of cardiac cycles, a respective one of a plurality of datasets at least in part from a respective second portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each respective oneof the plurality of data sets derived only from particular data thatexcludes the identified excludable portion of the intra-cardiac voltagedata sampled by the electrode during the respective one of the pluralityof cardiac cycles. The method may include causing the input-outputdevice system to concurrently display the plurality of data sets.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system communicatively connected to aninput-output device system. The program may include a data receptionmodule configured to cause reception of intra-cardiac voltage data viathe input-output device system, the intra-cardiac voltage data sampledby an electrode over a period of time including a plurality of cardiaccycles. The program may include a cardiac event identification moduleconfigured to identify a respective occurrence of a particular cardiacevent in each of the plurality of cardiac cycles. The program mayinclude a data identification module configured to identify, for eachrespective one of the plurality of cardiac cycles, a respective firstportion of the intra-cardiac voltage data sampled during the respectiveone of the plurality of cardiac cycles, each respective first portion ofthe intra-cardiac voltage data identified in accordance with apredetermined temporal relationship with the respective occurrence ofthe particular cardiac event identified in the respective one of theplurality of cardiac cycles. The program may include an excludable dataidentification module configured to identify, for each respective one ofthe plurality of cardiac cycles, a particular portion of theintra-cardiac voltage data sampled during the respective one of theplurality of cardiac cycles as an excludable portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each identifiedexcludable portion of the intra-cardiac voltage data including some butnot all of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles. Theprogram may include a data derivation module configured to derive, foreach respective one of the plurality of cardiac cycles, a respective oneof a plurality of data sets at least in part from a respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles, eachrespective one of the plurality of data sets derived only fromparticular data that excludes the identified excludable portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. The program mayinclude a display module configured to cause the input-output devicesystem to concurrently display the plurality of data sets.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The program may include data receptioninstructions configured to cause reception of intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time including a plurality ofcardiac cycles. The program may include data identification instructionsconfigured to identify, for each respective one of the plurality ofcardiac cycles, a respective first portion of the intra-cardiac voltagedata sampled during the respective one of the plurality of cardiaccycles, each respective first portion of the intra-cardiac voltage dataidentified as including a maximum absolute value of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles, each identified first portion of theintra-cardiac voltage data including some but not all of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. The program mayinclude data derivation instructions configured to derive, for eachrespective one of the plurality of cardiac cycles, a respective one of aplurality of data sets at least in part from a respective second portionof the intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each respective oneof the plurality of data sets derived only from particular data thatexcludes the identified first portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles. The program may include display instructions configuredto cause the input-output device system to concurrently display theplurality of data sets.

In some embodiments, the data derivation instructions may be configuredto derive each respective one of the plurality of data sets at least inpart from a first respective part of the respective second portion ofthe intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, the first respectivepart including a maximum value as compared with other parts of therespective second portion of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles. In some embodiments, the data derivation instructions may beconfigured to derive each respective one of the plurality of data setsat least in part from a second respective part of the respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles, the secondrespective part including a minimum value as compared with other partsof the respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles.

In some embodiments, each of the plurality of data sets may include datarepresentative of a maximum absolute value in the respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles. In someembodiments, each of the plurality of data sets may include datarepresentative of a difference between a maximum value and a minimumvalue in the respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles. In some embodiments, each of the plurality of data setsmay include data representative of a difference between two values inthe respective second portion of the intra-cardiac voltage data sampledby the electrode during the respective one of the plurality of cardiaccycles. In some embodiments, the program may include activationinstructions configured to cause the electrode to transmit energysufficient to cause tissue ablation at least during the sampling of theintra-cardiac voltage data by the electrode over the period of timeincluding the plurality of cardiac cycles.

In some embodiments, the display instructions may be configured to causethe input-output device system to sequentially display each of theplurality of data sets until all of the plurality of data sets areconcurrently displayed by the input-output device system. In someembodiments, the display instructions may be configured to cause theinput-output device system to sequentially display each of the pluralityof data sets according to a first order that is consistent with an orderof the plurality of cardiac cycles during the period of time. In someembodiments, the display instructions may be configured to cause theinput-output device system to display the plurality of the data sets ina first spatial order representative of an order of the plurality ofcardiac cycles during the period of time. In some embodiments, thedisplay instructions may be configured to cause the input-output devicesystem to sequentially display each of the plurality of data setsaccording to a first order that is consistent with the order of theplurality of cardiac cycles during the period of time. In someembodiments, the display instructions may be configured to cause theinput-output device system to display an intra-cardiac electrogramconcurrently with the plurality of data sets, the intra-cardiacelectrogram derived from at least a portion of the intra-cardiac voltagedata sampled by the electrode, and the intra-cardiac electrogramundergoing a biphasic to monophasic transformation during at least partof the sequential display of each of the plurality of data sets. In someembodiments, the display instructions may be configured to cause theinput-output device system to display a monophasic intra-cardiacelectrogram concurrently with the plurality of data sets, the monophasicintra-cardiac electrogram derived from at least a portion of theintra-cardiac voltage data sampled by the electrode, and the monophasicintra-cardiac electrogram reducing in amplitude with each sequentialdisplay of each of at least some of the plurality of data sets. Themonophasic intra-cardiac electrogram has a positive polarity in someembodiments.

In some embodiments, the display instructions may be configured to causethe input-output device system to display an intra-cardiac electrogramconcurrently with the plurality of data sets, the intra-cardiacelectrogram derived from at least a portion of the intra-cardiac voltagedata sampled by the electrode. In some embodiments, the intra-cardiacelectrogram is a monophasic intra-cardiac electrogram. The monophasicintra-cardiac electrogram may have a positive polarity in someembodiments. In some embodiments, the display instructions may beconfigured to cause the input-output device system to display theplurality of data sets among at least a portion of the intra-cardiacelectrogram.

In some embodiments, each of the plurality of data sets may include arespective one of a plurality of voltage magnitude sets. In someembodiments, each respective one of the plurality of voltage magnitudesets is frequency-weighted. In some embodiments, each respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles includesfrequency-weighted data. In some embodiments, the intra-cardiac voltagedata may be sampled by the electrode while positioned at a same locationin an intra-cardiac cavity during each of the plurality of cardiaccycles in the period of time.

Various systems may include combinations and subsets of all the systemssummarized above or otherwise described herein.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The data processing device system may beconfigured by the program at least to receive intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time including a plurality ofcardiac cycles. The data processing device system may be configured bythe program at least to identify, for each respective one of theplurality of cardiac cycles, a respective first portion of theintra-cardiac voltage data sampled during the respective one of theplurality of cardiac cycles, each respective first portion of theintra-cardiac voltage data identified as including a maximum absolutevalue of the intra-cardiac voltage data sampled by the electrode duringthe respective one of the plurality of cardiac cycles, each identifiedfirst portion of the intra-cardiac voltage data including some but notall of the intra-cardiac voltage data sampled by the electrode duringthe respective one of the plurality of cardiac cycles. The dataprocessing device system may be configured by the program at least toderive, for each respective one of the plurality of cardiac cycles, arespective one of a plurality of data sets at least in part from arespective second portion of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles, each respective one of the plurality of data sets derived onlyfrom particular data that excludes the identified first portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. The data processingdevice system may be configured by the program at least to cause theinput-output device system to concurrently display the plurality of datasets.

In some embodiments, an intra-cardiac voltage data display method isexecuted by a data processing device system according to a programstored by a memory device system communicatively connected to the dataprocessing device system, the data processing device system furthercommunicatively connected to an input-output device system. The methodmay include receiving intra-cardiac voltage data via the input-outputdevice system, the intra-cardiac voltage data sampled by an electrodeover a period of time including a plurality of cardiac cycles. Themethod may include identifying, for each respective one of the pluralityof cardiac cycles, a respective first portion of the intra-cardiacvoltage data sampled during the respective one of the plurality ofcardiac cycles, each respective first portion of the intra-cardiacvoltage data identified as including a maximum absolute value of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each identified firstportion of the intra-cardiac voltage data including some but not all ofthe intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. The method mayinclude deriving, for each respective one of the plurality of cardiaccycles, a respective one of a plurality of data sets at least in partfrom a respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles, each respective one of the plurality of data setsderived only from particular data that excludes the identified firstportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles. The methodmay include causing the input-output device system to concurrentlydisplay the plurality of data sets.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system communicatively connected to aninput-output device system. The program may include a data receptionmodule configured to cause reception of intra-cardiac voltage data viathe input-output device system, the intra-cardiac voltage data sampledby an electrode over a period of time including a plurality of cardiaccycles. The program may include a data identification module configuredto identify, for each respective one of the plurality of cardiac cycles,a respective first portion of the intra-cardiac voltage data sampledduring the respective one of the plurality of cardiac cycles, eachrespective first portion of the intra-cardiac voltage data identified asincluding a maximum absolute value of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles, each identified first portion of the intra-cardiacvoltage data including some but not all of the intra-cardiac voltagedata sampled by the electrode during the respective one of the pluralityof cardiac cycles. The program may include a data derivation moduleconfigured to derive, for each respective one of the plurality ofcardiac cycles, a respective one of a plurality of data sets at least inpart from a respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles, each respective one of the plurality of data setsderived only from particular data that excludes the identified firstportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles. Theprogram may include a display module configured to cause theinput-output device system to concurrently display the plurality of datasets.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The program may include data receptioninstructions configured to cause reception of intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time including a plurality ofcardiac cycles that include at least a first cardiac cycle and a secondcardiac cycle other than the first cardiac cycle, the second cardiaccycle occurring after the first cardiac cycle. The program may includedisplay instructions configured to cause the input-output device systemto display a plurality of data sets including a concurrently displayedfirst data set and a concurrently displayed second data set. The programmay include data derivation instructions configured to derive the firstdata set at least in part from the intra-cardiac voltage data sampled bythe electrode during a first time in the first cardiac cycle, and fromthe intra-cardiac voltage data sampled by the electrode during a secondtime in the first cardiac cycle, the second time occurring after thefirst time. The data derivation instructions may be configured to derivethe second data set only from particular data, the particular dataexcluding at least some of the intra-cardiac voltage data sampled by theelectrode during the second time in the first cardiac cycle, and theparticular data including at least some of the intra-cardiac voltagedata sampled by the electrode during the first time in the first cardiaccycle and at least some of the intra-cardiac voltage data sampled by theelectrode during the second cardiac cycle.

In some embodiments, the data derivation instructions may be configuredto derive the first data set at least in part from at least part of theintra-cardiac voltage data sampled by the electrode during the secondcardiac cycle. In some embodiments, the concurrently displayed firstdata set may include at least a portion of an intra-cardiac electrogram.In some embodiments, the concurrently displayed first data set mayinclude at least a portion of a monophasic intra-cardiac electrogram.The monophasic intra-cardiac electrogram may have a positive polarity insome embodiments. In some embodiments, the displayed portion of theintra-cardiac electrogram may include a particular biphasic portion ofthe portion of the intra-cardiac electrogram derived from at least someof the intra-cardiac voltage data sampled by the electrode during thefirst cardiac cycle, and a particular monophasic portion of the portionof the intra-cardiac electrogram derived from the at least part of theintra-cardiac voltage data sampled by the electrode during the secondcardiac cycle. In some embodiments, the displayed portion of theintra-cardiac electrogram may include a first monophasic portion of theportion of the intra-cardiac electrogram derived from at least some ofthe intra-cardiac voltage data sampled by the electrode during the firstcardiac cycle, and a second monophasic portion of the portion of theintra-cardiac electrogram derived from the at least part of theintra-cardiac voltage data sampled by the electrode during the secondcardiac cycle. Each of the first and the second monophasic portions ofthe intra-cardiac electrogram may have a positive polarity in someembodiments. in some embodiments, an amplitude of the first monophasicportion of the portion of the intra-cardiac electrogram may be greaterthan an amplitude of the second monophasic portion of the portion of theintra-cardiac electrogram.

In some embodiments, the data derivation instructions may be configuredto derive the first data set at least in part from a particular portionof the intra-cardiac voltage data sampled by the electrode during thesecond cardiac cycle, and the particular data may exclude the particularportion of the intra-cardiac voltage data sampled by the electrodeduring the second cardiac cycle. In some embodiments, the particulardata may exclude a maximum absolute value of the intra-cardiac voltagedata sampled by the electrode during the first cardiac cycle. In someembodiments, the particular data may exclude at least some of a portionof the intra-cardiac voltage data sampled by the electrode during anoccurrence of ventricular systole in the first cardiac cycle.

In some embodiments, the concurrently displayed second data set mayinclude data representative of a maximum absolute value of theintra-cardiac voltage data sampled by the electrode during the firsttime in the first cardiac cycle. In some embodiments, the concurrentlydisplayed second data set may include data representative of adifference between two values of the intra-cardiac voltage data sampledby the electrode during the first time in the first cardiac cycle. Insome embodiments, the concurrently displayed second data set may includedata representative of a difference between a maximum value of theintra-cardiac voltage data sampled by the electrode during the firsttime in the first cardiac cycle and a minimum value of the intra-cardiacvoltage data sampled by the electrode during the first time in the firstcardiac cycle. In some embodiments, the concurrently displayed seconddata set may include data derived from (a) a minimum value of theintra-cardiac voltage data sampled by the electrode during the firsttime in the first cardiac cycle; (b) a maximum value of theintra-cardiac voltage data sampled by the electrode during the firsttime in the first cardiac cycle; or both (a) and (b). In someembodiments, the concurrently displayed second data set may includefirst data representative of a difference between two values of theintra-cardiac voltage data sampled by the electrode during the firstcardiac cycle and second data representative of a difference between twovalues of the intra-cardiac voltage data sampled by the electrode duringthe second cardiac cycle.

In some embodiments, the program may include activation instructionsconfigured to cause a transmission of energy sufficient for tissueablation at least during the sampling of the intra-cardiac voltage databy the electrode during each of at least the first cardiac cycle and thesecond cardiac cycle. In some embodiments, the concurrently displayedfirst data set may include at least a portion of an intra-cardiacelectrogram. In some embodiments, the program may include identificationinstructions configured to identify a duration from a time from a startof the tissue ablation to a time of a maximum voltage peak in at leastthe portion of the intra-cardiac electrogram. The program may includetissue thickness determination instructions configured to determine athickness of tissue subject to the tissue ablation based at least upon acomparison of the identified duration with a predetermined threshold.The program may include thickness indication instructions configured tooutput a tissue-thickness indication via the input-output device systemindicating a result of the determination of the thickness of the tissue.

In some embodiments, the program may include identification instructionsconfigured to identify a duration from a time from a start of the tissueablation to a time of a maximum voltage peak in at least a portion ofthe second data set. The program may include tissue thicknessdetermination instructions configured to determine a thickness of tissuesubject to the tissue ablation based at least upon a comparison of theidentified duration with a predetermined threshold. The program mayinclude thickness indication instructions configured to output atissue-thickness indication via the input-output device systemindicating a result of the determination of the thickness of the tissue.

In some embodiments, the program may include identification instructionsconfigured to identify a curve-slope from a time of a maximum voltagepeak in at least a portion of the second data set to a time indicating abeginning of a pre-plateau transitional region in at least the portionof the second data set. The program may include tissue thicknessdetermination instructions configured to determine a thickness of tissuesubject to the tissue ablation based at least upon a comparison of theidentified curve-slope with a predetermined curve-slope. The program mayinclude thickness indication instructions configured to output atissue-thickness indication via the input-output device systemindicating a result of the determination of the thickness of the tissue.

In some embodiments, the display instructions may be configured to causethe input-output device system to concurrently display the second dataset at least by displaying (a) the data included in the second data setand derived at least in part from the at least some of the intra-cardiacvoltage data sampled by the electrode during the second cardiac cyclesequentially after (b) the data included in the second data set andderived at least in part from the intra-cardiac voltage data sampled bythe electrode during the first time in the first cardiac cycle whilecontinuing to display (b) to cause both (a) and (b) to be concurrentlydisplayed. In some embodiments, the display instructions may beconfigured to cause the input-output device system to display anintra-cardiac electrogram concurrently with at least the concurrentlydisplayed second data set, the intra-cardiac electrogram derived from atleast a portion of the intra-cardiac voltage data sampled by theelectrode, and the intra-cardiac electrogram undergoing a biphasic tomonophasic transformation during the display of the concurrentlydisplayed second data set. In some embodiments, the display instructionsmay be configured to cause the input-output device system to display amonophasic intra-cardiac electrogram concurrently with at least theconcurrently displayed second data set, the monophasic intra-cardiacelectrogram including a plurality of portions, each portion of themonophasic intra-cardiac electrogram corresponding to a respectiveparticular cardiac event occurring in a respective one of the pluralityof cardiac cycles, the particular cardiac events being a same cardiacevent, and amplitudes of the particular cardiac events, as representedin the monophasic intra-cardiac electrogram by the plurality ofportions, decreasing over a span including at least the first cardiaccycle and the second cardiac cycle. Each portion of the monophasicintra-cardiac electrogram may have a positive polarity in someembodiments.

In some embodiments, the program may include cardiac eventidentification instructions configured to identify a respectiveoccurrence of a particular cardiac event in each respective one of theplurality of cardiac cycles. The program may include data identificationinstructions configured to identify, for each respective one of theplurality of cardiac cycles, a particular portion of the intra-cardiacvoltage data sampled during the respective one of the plurality ofcardiac cycles, each particular portion of the intra-cardiac voltagedata sampled by the electrode during the respective one of the pluralityof cardiac cycles including some but not all of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles, each particular portion of theintra-cardiac voltage data identified in accordance with a predeterminedtemporal relationship with the occurrence of the particular cardiacevent identified in the respective one of the plurality of cardiaccycles. The particular data may exclude at least some of each identifiedparticular portion of the intra-cardiac voltage data sampled by theelectrode during the respective one of the first cardiac cycle and thesecond cardiac cycle.

In some embodiments, the display instructions may be configured to causethe input-output device system to concurrently display the concurrentlydisplayed first data set and the concurrently displayed second data set.In some embodiments, the display instructions may be configured to causethe input-output device system to display the concurrently displayedfirst data set and the concurrently displayed second data set in asuperimposed configuration.

In some embodiments, each of the plurality of data sets may include arespective one of a plurality of voltage magnitude sets. In someembodiments, each respective one of the plurality of voltage magnitudesets may be frequency-weighted.

Various systems may include combinations and subsets of all the systemssummarized above or otherwise described herein.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The data processing device system may beconfigured by the program at least to receive intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time including a plurality ofcardiac cycles that include at least a first cardiac cycle and a secondcardiac cycle other than the first cardiac cycle, the second cardiaccycle occurring after the first cardiac cycle. The data processingdevice system may be configured by the program at least to cause theinput-output device system to display a plurality of data sets includinga concurrently displayed first data set and a concurrently displayedsecond data set. The data processing device system may be configured bythe program at least to derive the first data set at least in part fromthe intra-cardiac voltage data sampled by the electrode during a firsttime in the first cardiac cycle, and from the intra-cardiac voltage datasampled by the electrode during a second time in the first cardiaccycle, the second time occurring after the first time. The dataprocessing device system may be configured by the program at least toderive the second data set only from particular data, the particulardata excluding at least some of the intra-cardiac voltage data sampledby the electrode during the second time in the first cardiac cycle, andthe particular data including at least some of the intra-cardiac voltagedata sampled by the electrode during the first time in the first cardiaccycle and at least some of the intra-cardiac voltage data sampled by theelectrode during the second cardiac cycle.

In some embodiments, an intra-cardiac voltage data display method isexecuted by a data processing device system according to a programstored by a memory device system communicatively connected to the dataprocessing device system, the data processing device system furthercommunicatively connected to an input-output device system. The methodmay include receiving intra-cardiac voltage data via the input-outputdevice system, the intra-cardiac voltage data sampled by an electrodeover a period of time including a plurality of cardiac cycles thatinclude at least a first cardiac cycle and a second cardiac cycle otherthan the first cardiac cycle, the second cardiac cycle occurring afterthe first cardiac cycle. The method may include causing the input-outputdevice system to display a plurality of data sets including aconcurrently displayed first data set and a concurrently displayedsecond data set. The method may include deriving the first data set atleast in part from the intra-cardiac voltage data sampled by theelectrode during a first time in the first cardiac cycle, and from theintra-cardiac voltage data sampled by the electrode during a second timein the first cardiac cycle, the second time occurring after the firsttime. The method may include deriving the second data set only fromparticular data, the particular data excluding at least some of theintra-cardiac voltage data sampled by the electrode during the secondtime in the first cardiac cycle, and the particular data including atleast some of the intra-cardiac voltage data sampled by the electrodeduring the first time in the first cardiac cycle and at least some ofthe intra-cardiac voltage data sampled by the electrode during thesecond cardiac cycle.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system communicatively connected to aninput-output device system. The program may include a data receptionmodule configured to cause reception of intra-cardiac voltage data viathe input-output device system, the intra-cardiac voltage data sampledby an electrode over a period of time including a plurality of cardiaccycles that include at least a first cardiac cycle and a second cardiaccycle other than the first cardiac cycle, the second cardiac cycleoccurring after the first cardiac cycle. The program may include adisplay module configured to cause the input-output device system todisplay a plurality of data sets including a concurrently displayedfirst data set and a concurrently displayed second data set. The programmay include a data derivation module configured to derive the first dataset at least in part from the intra-cardiac voltage data sampled by theelectrode during a first time in the first cardiac cycle, and from theintra-cardiac voltage data sampled by the electrode during a second timein the first cardiac cycle, the second time occurring after the firsttime. The data derivation module may be configured to derive the seconddata set only from particular data, the particular data excluding atleast some of the intra-cardiac voltage data sampled by the electrodeduring the second time in the first cardiac cycle, and the particulardata including at least some of the intra-cardiac voltage data sampledby the electrode during the first time in the first cardiac cycle and atleast some of the intra-cardiac voltage data sampled by the electrodeduring the second cardiac cycle.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The program may include data receptioninstructions configured to cause reception of intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time that includes a pluralityof cardiac cycles. The program may include data derivation instructionsconfigured to derive at least a first graphical distribution of dataderived at least in part from a first portion of the receivedintra-cardiac voltage data and a second graphical distribution of dataderived at least in part from a second portion of the receivedintra-cardiac voltage data. The program may include display instructionsconfigured to cause the input-output device system to concurrentlydisplay at least the first graphical distribution of data and the secondgraphical distribution of data, the displayed first graphicaldistribution including first data displayed across a first time scaleand the displayed second graphical distribution including second datadisplayed across a second time scale having a different scale than thefirst time scale, the displayed first and second displayed graphicaldistributions concurrently displayed in a superimposed configuration.

In some embodiments, the data derivation instructions may be configuredto derive the second graphical distribution of data only from particulardata, the particular data excluding, for each respective one of at leastthree of the plurality of cardiac cycles, a respective particular partof the intra-cardiac voltage data sampled by the electrode during therespective one of the at least three of the plurality of cardiac cycles,each respective particular part including some but not all of theintra-cardiac voltage data sampled by the electrode during therespective one of the at least three of the plurality of cardiac cycles,and wherein the data derivation instructions are configured to derivethe first graphical distribution of data from data that includes each ofthe respective particular parts.

In some embodiments, the program may include cardiac eventidentification instructions configured to identify a respectiveoccurrence of a particular cardiac event in each respective one of theat least three of the plurality of cardiac cycles. The dataidentification instructions may be configured to identify, for eachrespective one of the at least three of the plurality of cardiac cycles,a particular portion of the intra-cardiac voltage data sampled duringthe respective one of the at least three of the plurality of cardiaccycles, each particular portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the at least threeof the plurality of cardiac cycles including some but not all of theintra-cardiac voltage data sampled by the electrode during therespective one of the at least three of the plurality of cardiac cycles,each particular portion of the intra-cardiac voltage data identified inaccordance with a predetermined temporal relationship with theoccurrence of the particular cardiac event identified in the respectiveone of the at least three of the plurality of cardiac cycles. Theparticular data may exclude at least some of each identified particularportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the at least three of the plurality ofcardiac cycles. In some embodiments, the data derivation instructionsmay be configured to derive the first graphical distribution of datafrom the respective particular portions.

In some embodiments, the displayed first graphical distribution mayinclude a first group of voltage magnitudes displayed across the firsttime scale, and the displayed second graphical distribution may includea second group of voltage magnitudes displayed across the second timescale. In some embodiments, (a) the first group of voltage magnitudes(b) the second group of voltage magnitudes, or each of (a) and (b) isfrequency-weighted.

Various systems may include combinations and subsets of all the systemssummarized above or otherwise described herein.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The data processing device system may beconfigured by the program at least to receive intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time that includes a pluralityof cardiac cycles. The data processing device system may be configuredby the program at least to derive at least a first graphicaldistribution of data derived at least in part from a first portion ofthe received intra-cardiac voltage data and a second graphicaldistribution of data derived at least in part from a second portion ofthe received intra-cardiac voltage data. The data processing devicesystem may be configured by the program at least to cause theinput-output device system to concurrently display at least the firstgraphical distribution of data and the second graphical distribution ofdata, the displayed first graphical distribution including first datadisplayed across a first time scale and the displayed second graphicaldistribution including second data displayed across a second time scalehaving a different scale than the first time scale, the displayed firstand second displayed graphical distributions concurrently displayed in asuperimposed configuration.

In some embodiments, an intra-cardiac voltage data display method isexecuted by a data processing device system according to a programstored by a memory device system communicatively connected to the dataprocessing device system, the data processing device system furthercommunicatively connected to an input-output device system. The methodmay include receiving intra-cardiac voltage data via the input-outputdevice system, the intra-cardiac voltage data sampled by an electrodeover a period of time that includes a plurality of cardiac cycles. Themethod may include deriving at least a first graphical distribution ofdata derived at least in part from a first portion of the receivedintra-cardiac voltage data and a second graphical distribution of dataderived at least in part from a second portion of the receivedintra-cardiac voltage data. The method may include causing theinput-output device system to concurrently display at least the firstgraphical distribution of data and the second graphical distribution ofdata, the displayed first graphical distribution including first datadisplayed across a first time scale and the displayed second graphicaldistribution including second data displayed across a second time scalehaving a different scale than the first time scale, the displayed firstand second displayed graphical distributions concurrently displayed in asuperimposed configuration.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system communicatively connected to aninput-output device system. The program may include a data receptionmodule configured to cause reception of intra-cardiac voltage data viathe input-output device system, the intra-cardiac voltage data sampledby an electrode over a period of time that includes a plurality ofcardiac cycles. The program may include a data derivation moduleconfigured to derive at least a first graphical distribution of dataderived at least in part from a first portion of the receivedintra-cardiac voltage data and a second graphical distribution of dataderived at least in part from a second portion of the receivedintra-cardiac voltage data. The program may include a display moduleconfigured to cause the input-output device system to concurrentlydisplay at least the first graphical distribution of data and the secondgraphical distribution of data, the displayed first graphicaldistribution including first data displayed across a first time scaleand the displayed second graphical distribution including second datadisplayed across a second time scale having a different scale than thefirst time scale, the displayed first and second displayed graphicaldistributions concurrently displayed in a superimposed configuration.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The program may include data receptioninstructions configured to cause reception of intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by a sensing electrode over a period of time that includes aplurality of cardiac cycles. The program may include activationinstructions configured to cause an ablation electrode to transmitenergy sufficient for tissue ablation at least during the sampling ofthe intra-cardiac voltage data by the sensing electrode. The program mayinclude data derivation instructions configured to derive at least aplurality of voltage values, each of the plurality of voltage valuesderived at least in part from a respective portion of the receivedintra-cardiac voltage data, each of the plurality of voltage valuescorrelated with a respective time within a time range during which therespective portion of the of the received intra-cardiac voltage data wassampled by the sensing electrode. The program may include identificationinstructions configured to identify a duration from a time of a start ofthe tissue ablation to the respective time correlated with a particularone of the respective voltage values, the particular one of therespective voltage values being a maximum value as compared with othersof the plurality of voltage values. The program may include tissuethickness determination instructions configured to determine a thicknessof tissue subject to the tissue ablation based at least upon acomparison of the identified duration with a predetermined threshold.The program may include thickness indication instructions configured tooutput a tissue-thickness indication via the input-output device systemindicating a result of the determination of the thickness of the tissue.

In some embodiments, each respective portion of the receivedintra-cardiac voltage data includes intra-cardiac voltage data sampledby the sensing electrode during a respective one of the plurality ofcardiac cycles, but does not include any intra-cardiac voltage datasampled by the sensing electrode during any of the plurality of cardiaccycles other than the respective one of the plurality of cardiac cycles,and wherein each respective portion from which a respective one of atleast three of the plurality of voltage values is derived representssome, but not all, of the intra-cardiac voltage data sampled by thesensing electrode during the respective one of the plurality of cardiaccycles. In some embodiments, the respective portions from which the atleast three of the plurality of voltage values are derived from aninterrupted sequence of the sampled intra-cardiac voltage data in whicheach succeeding one of the respective portions from which the at leastthree of the plurality of voltage values are derived is separated froman immediately preceding one of the respective portions from which theat least three of the plurality of voltage values are derived byrespective portion of the sampled intra-cardiac data which does not formpart of any of the respective portions from which the at least three ofthe plurality of voltage values is derived from. In some embodiments,the program may include cardiac event identification instructionsconfigured to identify a respective occurrence of a particular cardiacevent in each respective one of the at least three of the plurality ofcardiac cycles, and each respective portion from which a respective oneof at least three of the plurality of voltage values is derived isdetermined in accordance with a predetermined temporal relationship withthe occurrence of the particular cardiac event identified in therespective one of the at least three of the plurality of cardiac cycles.

In some embodiments, the program may include display instructionsconfigured to display, via the input-output device system, the pluralityof voltage values. In some embodiments, the program may include displayinstructions configured to display, via the input-output device system,a distribution of the plurality of voltage values across a time scale.In some embodiments, the display instructions are configured to display,via the input-output device system, an intra-cardiac electrogram derivedfrom the intra-cardiac voltage data sampled by the sensing electrode,the displayed intra-cardiac electrogram concurrently displayed with atleast part of the distribution according to the display instructions andincluding a visual characteristic set visually distinct from a visualcharacteristic set comprised by the displayed at least part of thedistribution.

In some embodiments, the program may include display instructionsconfigured to display the plurality of voltage values as anintra-cardiac electrogram. In some embodiments, the ablation electrodeis provided by the sensing electrode.

Various systems may include combinations and subsets of all the systemssummarized above or otherwise described herein.

In some embodiments, an intra-cardiac voltage data display system may besummarized as including a data processing device system, an input-outputdevice system communicatively connected to the data processing devicesystem, and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system. The data processing device system may beconfigured by the program at least to receive intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by a sensing electrode over a period of time that includes aplurality of cardiac cycles. The data processing device system may beconfigured by the program at least to cause an ablation electrode totransmit energy sufficient for tissue ablation at least during thesampling of the intra-cardiac voltage data by the sensing electrode. Thedata processing device system may be configured by the program at leastto derive at least a plurality of voltage values, each of the pluralityof voltage values derived at least in part from a respective portion ofthe received intra-cardiac voltage data, each of the plurality ofvoltage values correlated with a respective time within a time rangeduring which the respective portion of the of the received intra-cardiacvoltage data was sampled by the sensing electrode. The data processingdevice system may be configured by the program at least to identify aduration from a time of a start of the tissue ablation to the respectivetime correlated with a particular one of the respective voltage values,the particular one of the respective voltage values being a maximumvalue as compared with others of the plurality of voltage values. Thedata processing device system may be configured by the program at leastto determine a thickness of tissue subject to the tissue ablation basedat least upon a comparison of the identified duration with apredetermined threshold. The data processing device system may beconfigured by the program at least to output a tissue-thicknessindication via the input-output device system indicating a result of thedetermination of the thickness of the tissue.

In some embodiments, an intra-cardiac voltage data display method isexecuted by a data processing device system according to a programstored by a memory device system communicatively connected to the dataprocessing device system, the data processing device system furthercommunicatively connected to an input-output device system. The methodmay include receiving intra-cardiac voltage data via the input-outputdevice system, the intra-cardiac voltage data sampled by a sensingelectrode over a period of time that includes a plurality of cardiaccycles. The method may include causing an ablation electrode to transmitenergy sufficient for tissue ablation at least during the sampling ofthe intra-cardiac voltage data by the sensing electrode. The method mayinclude deriving at least a plurality of voltage values, each of theplurality of voltage values derived at least in part from a respectiveportion of the received intra-cardiac voltage data, each of theplurality of voltage values correlated with a respective time within atime range during which the respective portion of the of the receivedintra-cardiac voltage data was sampled by the sensing electrode. Themethod may include identifying a duration from a time of a start of thetissue ablation to the respective time correlated with a particular oneof the respective voltage values, the particular one of the respectivevoltage values being a maximum value as compared with others of theplurality of voltage values. The method may include determining athickness of tissue subject to the tissue ablation based at least upon acomparison of the identified duration with a predetermined threshold.The method may include outputting a tissue-thickness indication via theinput-output device system indicating a result of the determination ofthe thickness of the tissue.

In some embodiments, a computer-readable storage medium system may besummarized as including one or more computer-readable storage mediumsstoring a program executable by one or more data processing devices of adata processing device system communicatively connected to aninput-output device system. The program may include a data receptionmodule configured to cause reception of intra-cardiac voltage data viathe input-output device system, the intra-cardiac voltage data sampledby a sensing electrode over a period of time that includes a pluralityof cardiac cycles. The program may include an activation moduleconfigured to cause an ablation electrode to transmit energy sufficientfor tissue ablation at least during the sampling of the intra-cardiacvoltage data by the sensing electrode. The program may include a dataderivation module configured to derive at least a plurality of voltagevalues, each of the plurality of voltage values derived at least in partfrom a respective portion of the received intra-cardiac voltage data,each of the plurality of voltage values correlated with a respectivetime within a time range during which the respective portion of the ofthe received intra-cardiac voltage data was sampled by the sensingelectrode. The program may include an identification module configuredto identify a duration from a time of a start of the tissue ablation tothe respective time correlated with a particular one of the respectivevoltage values, the particular one of the respective voltage valuesbeing a maximum value as compared with others of the plurality ofvoltage values. The program may include a tissue thickness determinationmodule configured to determine a thickness of tissue subject to thetissue ablation based at least upon a comparison of the identifiedduration with a predetermined threshold. The program may include athickness indication module configured to output a tissue-thicknessindication via the input-output device system indicating a result of thedetermination of the thickness of the tissue.

Any of the features of any of the methods discussed herein may becombined with any of the other features of any of the methods discussedherein. In addition, a computer program product may be provided thatcomprises program code portions for performing some or all of any of themethods and associated features thereof described herein, when thecomputer program product is executed by a computer or other computingdevice or device system. Such a computer program product may be storedon one or more computer-readable storage mediums.

In some embodiments, each of any or all of the computer-readable storagemediums or medium systems described herein is a non-transitorycomputer-readable storage medium or medium system including one or morenon-transitory computer-readable storage mediums storing the respectiveprogram(s).

Further, any or all of the methods and associated features thereofdiscussed herein may be implemented by all or part of a device system orapparatus, such as any of those described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is to be understood that the attached drawings are for purposes ofillustrating aspects of various embodiments and may include elementsthat are not to scale.

FIG. 1 includes a schematic representation of an intra-cardiac voltagedisplay system according to various example embodiments, theintra-cardiac voltage display system including a data processing devicesystem, an input-output device system, and a memory device system.

FIG. 2 includes a cutaway diagram of a heart showing a structure of atransducer-based device percutaneously placed in a left atrium of theheart according to various example embodiments.

FIG. 3A includes a partially schematic representation of a medicalsystem according to various example embodiments, the medical systemrepresenting at least a particular implementation of the intra-cardiacvoltage display system of FIG. 1, and the medical system including astructure of a transducer-based device shown in a delivery or unexpandedconfiguration, according to some embodiments.

FIG. 3B includes a different viewing direction of the structure of thetransducer-based device of FIG. 3A, according to some embodiments.

FIG. 3C includes a representation of the structure of thetransducer-based device of FIGS. 3A and 3B in a deployed or expandedconfiguration, according to some embodiments.

FIG. 3D includes a different viewing direction of the structure of thetransducer-based device of FIG. 3C, according to some embodiments.

FIG. 4 includes a schematic representation of a transducer-based devicethat includes a flexible circuit structure according to various exampleembodiments.

FIG. 5A includes a graphical interface according to various exampleembodiments, the graphical interface including a graphicalrepresentation of at least a portion of a transducer-based deviceincluding a plurality of transducer graphical elements.

FIG. 5B includes the graphical interface of FIG. 5A, but shows adifferent viewing direction of the transducer-based device as comparedto FIG. 5A in accordance with various example embodiments.

FIG. 5C includes the graphical representation provided by the graphicalinterface of FIG. 5A with the addition of various between graphicalelements positioned between various ones of transducer graphicalelements in accordance with various example embodiments.

FIG. 5D includes the graphical interface of FIG. 5C, but shows adifferent viewing direction of the transducer-based device as comparedto FIG. 5C in accordance with various example embodiments.

FIG. 5E includes a two-dimensional graphical representation of thetransducer-based device illustrated in FIGS. 5C and 5D in accordancewith various example embodiments.

FIG. 5F includes a two-dimensional graphical representation of thetransducer-based device illustrated in FIGS. 5A and 5B in accordancewith various example embodiments.

FIG. 5G includes an addition of various intra-cardiac information amongthe graphical representation of the transducer-based device illustratedin FIG. 5E in accordance with various example embodiments.

FIG. 5H includes an addition of various intra-cardiac information amongthe graphical representation of the transducer-based device illustratedin FIG. 5E, the intra-cardiac information representative of sampledintra-cardiac electrical data in accordance with various exampleembodiments.

FIGS. 5I, 5J, and 5K include an addition of various intra-cardiacinformation among the graphical representation of the transducer-baseddevice illustrated in FIG. 5E, the intra-cardiac information changingacross three successive times represented by FIGS. 5I, 5J, and 5K,respectively, in accordance with various example embodiments.

FIG. 5L includes a two-dimensional representation of a graphical pathprovided by a graphical interface, the graphical path including aselection of various graphical elements according to various exampleembodiments.

FIG. 5M includes a three-dimensional representation of a graphical pathprovided by a graphical interface, the graphical path including aselection of various graphical elements according to various exampleembodiments.

FIGS. 6A-6F include respective data generation and flow diagrams, whichmay implement various embodiments of a method by way of associatedcomputer-executable instructions, according to some example embodiments.

FIG. 7A includes a view of an intra-cardiac electrogram spanning aperiod of time that commences after a start of a tissue ablationprocedure according to some embodiments.

FIGS. 7B, 7C, and 7D include portions of the intra-cardiac electrogramof FIG. 7A at three successive times during the period of time displayedaccording to some embodiments.

FIG. 7E includes a low pass filtered version of the intra-cardiacelectrogram of FIG. 7A displayed according to some embodiments.

FIG. 7F includes a graph of a distribution of a plurality of data sets,each of the data sets derived from intra-cardiac voltage data sampledduring a respective one of a plurality of cardiac cycles, theintra-cardiac voltage data employed to derive the intra-cardiacelectrogram of FIG. 7E according to some embodiments.

FIGS. 8A, 8B, and 8C show changes in a displayed graphicalrepresentation at three successive times, the graphical representationincluding a concurrently displayed first data set and a concurrentlydisplayed second data set according to some embodiments.

FIGS. 8D, 8E, and 8F show changes in a displayed graphicalrepresentation at three successive times, the graphical representationincluding a concurrently displayed first data set and a concurrentlydisplayed second data set according to some embodiments.

FIGS. 9A, 9B, and 9C include portions of an intra-cardiac electrogram atthree successive times during the period of time displayed respectivelyin FIGS. 8A-8C according to some embodiments.

FIG. 9D includes a first concurrently displayed data set and a secondconcurrently displayed data set according to some embodiments.

FIGS. 10A and 10B provide in-vivo data, according to some embodiments.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various embodiments of theinvention. However, one skilled in the art will understand that theinvention may be practiced at a more general level without thesedetails. In other instances, well-known structures have not been shownor described in detail to avoid unnecessarily obscuring descriptions ofvarious embodiments of the invention.

Any reference throughout this specification to “one embodiment” or “anembodiment” or “an example embodiment” or “an illustrated embodiment” or“a particular embodiment” and the like means that a particular feature,structure or characteristic described in connection with the embodimentis included in at least one embodiment. Thus, any appearance of thephrase “in one embodiment” or “in an embodiment” or “in an exampleembodiment” or “in this illustrated embodiment” or “in this particularembodiment” or the like in this specification is not necessarily allreferring to one embodiment or a same embodiment. Furthermore, theparticular features, structures or characteristics of differentembodiments may be combined in any suitable manner to form one or moreother embodiments.

It is noted that, unless otherwise explicitly noted or required bycontext, the word “or” is used in this disclosure in a non-exclusivesense. In addition, unless otherwise explicitly noted or required bycontext, the word “set” is intended to mean one or more, and the word“subset” is intended to mean a set having the same or fewer elements ofthose present in the subset's parent or superset.

Further, the phrase “at least” is used herein at times to emphasize thepossibility that other elements can exist besides those explicitlylisted. However, unless otherwise explicitly noted (such as by the useof the term “only”) or required by context, non-usage herein of thephrase “at least” does not exclude the possibility that other elementscan exist besides those explicitly listed. For example, the phrase,“activation of at least transducer A” includes activation of transducerA by itself, as well as activation of transducer A and activation of oneor more other additional elements besides transducer A. In the samemanner, the phrase, “activation of transducer A” includes activation oftransducer A by itself, as well as activation of transducer A andactivation of one or more other additional elements besides transducerA. However, the phrase, “activation of only transducer A” includes onlyactivation of transducer A, and excludes activation of any othertransducers besides transducer A.

The word “ablation” as used in this disclosure should be understood toinclude any disruption to certain properties of tissue. Most commonly,the disruption is to the electrical conductivity and is achieved bytransferring thermal energy, which can be generated with resistive orradio-frequency (RF) techniques for example. Other properties, such asmechanical or chemical, and other means of disruption, such as optical,are included when the term “ablation” is used.

The word “fluid” as used in this disclosure should be understood toinclude any fluid that can be contained within a bodily cavity or canflow into or out of, or both into and out of a bodily cavity via one ormore bodily openings positioned in fluid communication with the bodilycavity. In the case of cardiac applications, fluid such as blood willflow into and out of various intra-cardiac cavities (e.g., a left atriumor right atrium).

The words “bodily opening” as used in this disclosure should beunderstood to include a naturally occurring bodily opening or channel orlumen; a bodily opening or channel or lumen formed by an instrument ortool using techniques that can include, but are not limited to,mechanical, thermal, electrical, chemical, and exposure or illuminationtechniques; a bodily opening or channel or lumen formed by trauma to abody; or various combinations of one or more of the above. Variouselements having respective openings, lumens or channels and positionedwithin the bodily opening (e.g., a catheter sheath) may be present invarious embodiments. These elements may provide a passageway through abodily opening for various devices employed in various embodiments.

The words “bodily cavity” as used in this disclosure should beunderstood to mean a cavity in a body. The bodily cavity may be a cavityor chamber provided in a bodily organ (e.g., an intra-cardiac cavity ofa heart).

The word “tissue” as used in some embodiments in this disclosure shouldbe understood to include any surface-forming tissue that is used to forma surface of a body or a surface within a bodily cavity, a surface of ananatomical feature or a surface of a feature associated with a bodilyopening positioned in fluid communication with the bodily cavity. Thetissue can include part or all of a tissue wall or membrane that definesa surface of the bodily cavity. In this regard, the tissue can form aninterior surface of the cavity that surrounds a fluid within the cavity.In the case of cardiac applications, tissue can include tissue used toform an interior surface of an intra-cardiac cavity such as a leftatrium or right atrium. In some embodiments, the word tissue can referto a tissue having fluidic properties (e.g., blood) and may be referredto as fluidic tissue.

The term “transducer” as used in this disclosure should be interpretedbroadly as any device capable of distinguishing between fluid andtissue, sensing temperature, creating heat, ablating tissue, sensing,sampling or measuring electrical activity of a tissue surface (e.g.,sensing, sampling or measuring intra-cardiac electrograms, or sensing,sampling or measuring intra-cardiac voltage data), stimulating tissue,or any combination thereof. A transducer can convert input energy of oneform into output energy of another form. Without limitation, atransducer can include an electrode that functions as, or as part of, asensing device included in the transducer, an energy delivery deviceincluded in the transducer, or both a sensing device and an energydelivery device included in the transducer. A transducer may beconstructed from several parts, which may be discrete components or maybe integrally formed. In this regard, although transducers, electrodes,or both transducers and electrodes are referenced with respect tovarious embodiments, it is understood that other transducers ortransducer elements may be employed in other embodiments. It isunderstood that a reference to a particular transducer in variousembodiments may also imply a reference to an electrode, as an electrodemay be part of the transducer as shown, e.g., with FIG. 4 discussedbelow.

The term “activation” as used in this disclosure should be interpretedbroadly as making active a particular function as related to varioustransducers disclosed in this disclosure. Particular functions mayinclude, but are not limited to, tissue ablation, sensing, sampling ormeasuring electrophysiological activity (e.g., sensing, sampling ormeasuring intra-cardiac electrogram information or sensing, sampling ormeasuring intra-cardiac voltage data), sensing, sampling or measuringtemperature and sensing, sampling or measuring electricalcharacteristics (e.g., tissue impedance or tissue conductivity). Forexample, in some embodiments, activation of a tissue ablation functionof a particular transducer is initiated by causing energy sufficient fortissue ablation from an energy source device system to be delivered tothe particular transducer. Alternatively, in this example, theactivation can be deemed to be initiated when the particular transducercauses a temperature sufficient for the tissue ablation due to theenergy provided by the energy source device system. Also in thisexample, the activation can last for a duration of time concluding whenthe ablation function is no longer active, such as when energysufficient for the tissue ablation is no longer provided to theparticular transducer. Alternatively, in this example, the activationperiod can be deemed to be concluded when the temperature caused by theparticular transducer is below the temperature sufficient for the tissueablation. In some contexts, however, the word “activation” can merelyrefer to the initiation of the activating of a particular function, asopposed to referring to both the initiation of the activating of theparticular function and the subsequent duration in which the particularfunction is active. In these contexts, the phrase or a phrase similar to“activation initiation” may be used.

The term “program” in this disclosure should be interpreted as a set ofinstructions or modules that can be executed by one or more componentsin a system, such a controller system or data processing device system,in order to cause the system to perform one or more operations. The setof instructions or modules can be stored by any kind of memory device,such as those described subsequently with respect to the memory devicesystem 130 or 330 shown in FIGS. 1 and 3, respectively. In addition,this disclosure sometimes describes that the instructions or modules ofa program are configured to cause the performance of a function. Thephrase “configured to” in this context is intended to include at least(a) instructions or modules that are presently in a form executable byone or more data processing devices to cause performance of the function(e.g., in the case where the instructions or modules are in a compiledand unencrypted form ready for execution), and (b) instructions ormodules that are presently in a form not executable by the one or moredata processing devices, but could be translated into the formexecutable by the one or more data processing devices to causeperformance of the function (e.g., in the case where the instructions ormodules are encrypted in a non-executable manner, but throughperformance of a decryption process, would be translated into a formready for execution). The word “module” can be defined as a set ofinstructions. In some instances, this disclosure describes that theinstructions or modules of a program perform a function. Suchdescriptions should be deemed to be equivalent to describing that theinstructions or modules are configured to cause the performance of thefunction.

Each of the phrases “derived from” or “derivation of” or “derivationthereof” or the like is intended to mean to come from at least some partof a source, be created from at least some part of a source, or bedeveloped as a result of a process in which at least some part of asource forms an input. For example, a data set derived from someparticular portion of data may include at least some part of theparticular portion of data, or may be created from at least part of theparticular portion of data, or may be developed in response to a datamanipulation process in which at least part of the particular portion ofdata forms an input. In some embodiments, a data set may be derived froma subset of the particular portion of data. In some embodiments, theparticular portion of data is analyzed to identify a particular subsetof the particular portion of data, and a data set is derived from thesubset. In various ones of these embodiments, the subset may includesome, but not all, of the particular portion of data. In someembodiments, changes in least one part of a particular portion of datamay result in changes in a data set derived at least in part from theparticular portion of data.

In this regard, each of the phrases “derived from” or “derivation of” or“derivation thereof” or the like is used herein at times merely toemphasize the possibility that such data or information may be modifiedor subject to one or more operations. For example, if a device generatesfirst data for display, the process of converting the generated firstdata into a format capable of being displayed may alter the first data.This altered form of the first data may be considered a derivative orderivation of the first data. For instance, the first data may be aone-dimensional array of numbers, but the display of the first data maybe a color-coded bar chart representing the numbers in the array. Foranother example, if the above-mentioned first data is transmitted over anetwork, the process of converting the first data into a formatacceptable for network transmission or understanding by a receivingdevice may alter the first data. As before, this altered form of thefirst data may be considered a derivative or derivation of the firstdata. For yet another example, generated first data may undergo amathematical operation, a scaling, or a combining with other data togenerate other data that may be considered derived from the first data.In this regard, it can be seen that data is commonly changing in form orbeing combined with other data throughout its movement through one ormore data processing device systems, and any reference to information ordata herein is intended to include these and like changes, regardless ofwhether or not the phrase “derived from” or “derivation of” or“derivation thereof” or the like is used in reference to the informationor data. As indicated above, usage of the phrase “derived from” or“derivation of” or “derivation thereof” or the like merely emphasizesthe possibility of such changes. Accordingly, the addition of ordeletion of the phrase “derived from” or “derivation of” or “derivationthereof” or the like should have no impact on the interpretation of therespective data or information. For example, the above-discussedcolor-coded bar chart may be considered a derivative of the respectivefirst data or may be considered the respective first data itself.

The word “device” and the phrase “device system” both are intended toinclude one or more physical devices or sub-devices (e.g., pieces ofequipment) that interact to perform one or more functions, regardless ofwhether such devices or sub-devices are located within a same housing ordifferent housings. In this regard, for example, this disclosuresometimes refers to a “catheter device”, but such catheter device couldequivalently be referred to as a “catheter device system”. The word“device” may equivalently be referred to as a “device system”.

In some contexts, the term “adjacent” is used in this disclosure torefer to objects that do not have another substantially similar objectbetween them. For example, object A and object B could be consideredadjacent if they contact each other (and, thus, it could be consideredthat no other object is between them), or if they do not contact eachother, but no other object that is substantially similar to object A,object B, or both objects A and B, depending on context, is betweenthem.

Further, the phrase “in response to” may be is used in this disclosure.For example, this phrase might be used in the following context, wherean event A occurs in response to the occurrence of an event B. In thisregard, such phrase can include, for example, that at least theoccurrence of the event B causes or triggers the event A.

Further, the phrase “graphical representation” used herein is intendedto include a visual representation presented via a display device andmay include computer-generated text, graphics, animations, or one ormore combinations thereof, which may include one or more visualrepresentations originally generated, at least in part, by animage-capture device, such as fluoroscopy images, CT scan images, MRIimages, etc.

Further still, example methods are described herein with respect to FIG.6. Such figures are described to include blocks associated withcomputer-executable instructions. It should be noted that the respectiveinstructions associated with any such blocks herein need not be separateinstructions and may be combined with other instructions to form acombined instruction set. The same set of instructions may be associatedwith more than one block. In this regard, the block arrangement shown ineach of the method figures herein is not limited to an actual structureof any program or set of instructions or required ordering of methodtasks, and such method figures, according to some embodiments, merelyillustrate the tasks that instructions are configured to perform, forexample upon execution by a data processing device system in conjunctionwith interactions with one or more other devices or device systems.

FIG. 1 schematically illustrates an intra-cardiac voltage display system100 that may be employed to at least select, control, activate, ormonitor a function or activation of one or more transducers, accordingto some embodiments. The system 100 includes a data processing devicesystem 110, an input-output device system 120, and aprocessor-accessible memory device system 130. The processor-accessiblememory device system 130 and the input-output device system 120 arecommunicatively connected to the data processing device system 110.

The data processing device system 110 includes one or more dataprocessing devices that implement or execute, in conjunction with otherdevices, such as those in the system 100, the methods of variousembodiments, including the example methods of FIG. 6 described herein.Each of the phrases “data processing device”, “data processor”,“processor”, and “computer” is intended to include any data processingdevice, such as a central processing unit (CPU), a desktop computer, alaptop computer, a mainframe computer, a tablet computer, a personaldigital assistant, a cellular phone, and any other device for processingdata, managing data, or handling data, whether implemented withelectrical, magnetic, optical, biological components, or otherwise.

The memory device system 130 includes one or more processor-accessiblememory devices configured to store information, including theinformation needed to execute the methods of various embodiments,including the example methods of FIG. 6 described herein. The memorydevice system 130 may be a distributed processor-accessible memorydevice system including multiple processor-accessible memory devicescommunicatively connected to the data processing device system 110 via aplurality of computers and/or devices. On the other hand, the memorydevice system 130 need not be a distributed processor-accessible memorysystem and, consequently, may include one or more processor-accessiblememory devices located within a single data processing device.

Each of the phrases “processor-accessible memory” and“processor-accessible memory device” is intended to include anyprocessor-accessible data storage device, whether volatile ornonvolatile, electronic, magnetic, optical, or otherwise, including butnot limited to, registers, floppy disks, hard disks, Compact Discs,DVDs, flash memories, ROMs, and RAMs. In some embodiments, each of thephrases “processor-accessible memory” and “processor-accessible memorydevice” is intended to include a non-transitory computer-readablestorage medium. And in some embodiments, the memory device system 130can be considered a non-transitory computer-readable storage mediumsystem.

The phrase “communicatively connected” is intended to include any typeof connection, whether wired or wireless, between devices, dataprocessors, or programs between which data may be communicated. Further,the phrase “communicatively connected” is intended to include aconnection between devices or programs within a single data processor, aconnection between devices or programs located in different dataprocessors, and a connection between devices not located in dataprocessors at all. In this regard, although the memory device system 130is shown separately from the data processing device system 110 and theinput-output device system 120, one skilled in the art will appreciatethat the memory device system 130 may be located completely or partiallywithin the data processing device system 110 or the input-output devicesystem 120. Further in this regard, although the input-output devicesystem 120 is shown separately from the data processing device system110 and the memory device system 130, one skilled in the art willappreciate that such system may be located completely or partiallywithin the data processing system 110 or the memory device system 130,depending upon the contents of the input-output device system 120.Further still, the data processing device system 110, the input-outputdevice system 120, and the memory device system 130 may be locatedentirely within the same device or housing or may be separately located,but communicatively connected, among different devices or housings. Inthe case where the data processing device system 110, the input-outputdevice system 120, and the memory device system 130 are located withinthe same device, the system 100 of FIG. 1 can be implemented by a singleapplication-specific integrated circuit (ASIC) in some embodiments.

The input-output device system 120 may include a mouse, a keyboard, atouch screen, another computer, or any device or combination of devicesfrom which a desired selection, desired information, instructions, orany other data is input to the data processing device system 110. Theinput-output device system 120 may include a user-activatable controlsystem that is responsive to a user action. The user-activatable controlsystem may include at least one control element that may be activated ordeactivated on the basis of a particular user action. The input-outputdevice system 120 may include any suitable interface for receivinginformation, instructions or any data from other devices and systemsdescribed in various ones of the embodiments. In this regard, theinput-output device system 120 may include various ones of other systemsdescribed in various embodiments. For example, the input-output devicesystem 120 may include at least a portion a transducer-based devicesystem. The phrase “transducer-based device system” is intended toinclude one or more physical systems that include various transducers.The phrase “transducer-based device” is intended to include one or morephysical devices that include various transducers.

The input-output device system 120 also may include an image generatingdevice system, a display device system, a processor-accessible memorydevice, or any device or combination of devices to which information,instructions, or any other data is output by the data processing devicesystem 110. In this regard, if the input-output device system 120includes a processor-accessible memory device, such memory device may ormay not form part or all of the memory device system 130. Theinput-output device system 120 may include any suitable interface foroutputting information, instructions or data to other devices andsystems described in various ones of the embodiments. In this regard,the input-output device system 120 may include various other devices orsystems described in various embodiments. In some embodiments, theinput-output device system 120 may include one or more display devicesthat display one or more of the graphical interfaces of FIG. 5,described below.

Various embodiments of transducer-based devices are described herein.Some of the described devices are medical devices that arepercutaneously or intravascularly deployed. Some of the describeddevices are movable between a delivery or unexpanded configuration(e.g., FIGS. 3A, 3B discussed below) in which a portion of the device issized for passage through a bodily opening leading to a bodily cavity,and an expanded or deployed configuration (e.g., FIGS. 3C, 3D discussedbelow) in which the portion of the device has a size too large forpassage through the bodily opening leading to the bodily cavity. Anexample of an expanded or deployed configuration is when the portion ofthe transducer-based device is in its intended-deployed-operationalstate inside the bodily cavity. Another example of the expanded ordeployed configuration is when the portion of the transducer-baseddevice is being changed from the delivery configuration to theintended-deployed-operational state to a point where the portion of thedevice now has a size too large for passage through the bodily openingleading to the bodily cavity.

In some example embodiments, the device includes transducers that sensecharacteristics (e.g., convective cooling, permittivity, force) thatdistinguish between fluid, such as a fluidic tissue (e.g., blood), andtissue forming an interior surface of the bodily cavity. Such sensedcharacteristics can allow a medical system to map the cavity, forexample using positions of openings or ports into and out of the cavityto determine a position or orientation (e.g., pose), or both of theportion of the device in the bodily cavity. In some example embodiments,the described devices are capable of ablating tissue in a desiredpattern within the bodily cavity.

In some example embodiments, the devices are capable of sensing variouscardiac functions (e.g., electrophysiological activity includingintra-cardiac voltages). In some example embodiments, the devices arecapable of providing stimulation (e.g., electrical stimulation) totissue within the bodily cavity. Electrical stimulation may includepacing.

FIG. 2 is a representation of a transducer-based device 200 useful ininvestigating or treating a bodily organ, for example a heart 202,according to one example embodiment.

Transducer-based device 200 can be percutaneously or intravascularlyinserted into a portion of the heart 202, such as an intra-cardiaccavity like left atrium 204. In this example, the transducer-baseddevice 200 is part of a catheter 206 inserted via the inferior vena cava208 and penetrating through a bodily opening in transatrial septum 210from right atrium 212. In other embodiments, other paths may be taken.

Catheter 206 includes an elongated flexible rod or shaft memberappropriately sized to be delivered percutaneously or intravascularly.Various portions of catheter 206 may be steerable. Catheter 206 mayinclude one or more lumens (not shown). The lumen(s) may carry one ormore communications or power paths, or both. For example, the lumens(s)may carry one or more electrical conductors 216 (two shown in someembodiments). Electrical conductors 216 provide electrical connectionsto transducer-based device 200 that are accessible externally from apatient in which the transducer-based device 200 is inserted.

Transducer-based device 200 includes a frame or structure 218 whichassumes an unexpanded configuration for delivery to left atrium 204.Structure 218 is expanded (e.g., shown in a deployed or expandedconfiguration in FIG. 2) upon delivery to left atrium 204 to position aplurality of transducers 220 (three called out in FIG. 2) proximate theinterior surface formed by tissue 222 of left atrium 204. In someembodiments, at least some of the transducers 220 are used to sense aphysical characteristic of a fluid (e.g., blood) or tissue 222, or both,that may be used to determine a position or orientation (e.g., pose), orboth, of a portion of a device 200 within, or with respect to leftatrium 204. For example, transducers 220 may be used to determine alocation of pulmonary vein ostia (not shown) or a mitral valve 226, orboth. In some embodiments, at least some of the transducers 220 may beused to selectively ablate portions of the tissue 222. For example, someof the transducers 220 may be used to ablate a pattern around the bodilyopenings, ports or pulmonary vein ostia, for instance to reduce oreliminate the occurrence of atrial fibrillation. In some embodiments, atleast some of the transducers 220 are used to ablate cardiac tissue. Insome embodiments, at least some of the transducers 220 are used to senseor sample intra-cardiac voltage data or sense or sample intra-cardiacelectrogram data. In some embodiments, at least some of the transducers220 are used to sense or sample intra-cardiac voltage data or sense orsample intra-cardiac electrogram data while at least some of thetransducers 220 are concurrently ablating cardiac tissue. In someembodiments, at least one of the sensing or sampling transducers 220 isprovided by at least one of the ablating transducers 220. In someembodiments, at least a first one of the transducers 220 senses orsamples intra-cardiac voltage data or intra-cardiac electrogram data ata location at least proximate to a tissue location ablated by at least asecond one of the transducers 220. In some embodiments, the first one ofthe transducers 220 is other than the second one of the transducers 220.

FIGS. 3A, 3B, 3C and 3D (collectively, FIG. 3) include atransducer-based device system (e.g., a portion thereof shownschematically) that includes a transducer-based device 300 according toone illustrated embodiment. Transducer-based device 300 includes aplurality of elongate members 304 (not all of the elongate memberscalled out in each of FIGS. 3A, 3B, 3C and 3D) and a plurality oftransducers 306 (not all of the transducers called out in FIG. 3) (someof the transducers 306 called out in FIG. 3D as 306 a, 306 b, 306 c, 306d, 306 e and 306 f). FIG. 3B includes a representation of a portion ofthe transducer-based device 300 shown in FIG. 3A but as viewed from adifferent viewing direction. FIG. 3D includes a representation of aportion of the transducer-based device 300 shown in FIG. 3C but asviewed from a different viewing direction. It is noted that for clarityof illustration, all the elongate members shown in FIGS. 3C and 3D arenot represented in FIGS. 3A and 3B. As will become apparent, theplurality of transducers 306 is positionable within a bodily cavity. Forexample, in some embodiments, the transducers 306 are able to bepositioned in a bodily cavity by movement into, within, or into andwithin the bodily cavity, with or without a change in a configuration ofthe plurality of transducers 306. In some embodiments, the plurality oftransducers 306 are arranged to form a two- or three-dimensionaldistribution, grid or array of the transducers capable of mapping,ablating or stimulating an inside surface of a bodily cavity or lumenwithout requiring mechanical scanning. As shown, for example, in FIGS.3A and 3B, the plurality of transducers 306 are arranged in adistribution receivable in a bodily cavity (not shown). In various onesof the FIG. 3, each of at least some of transducers 306 includes arespective electrode 315 (not all of the electrode 315 called out ineach of the FIG. 3, some of the electrodes in FIG. 3D called out as 315a, 315 b, 315 c, 315 d, 315 e and 315 f).

The elongate members 304 are arranged in a frame or structure 308 thatis selectively movable between an unexpanded or delivery configuration(e.g., as shown in FIGS. 3A, 3B) and an expanded or deployedconfiguration (e.g., as shown in FIGS. 3C, 3D) that may be used toposition elongate members 304 against a tissue surface within the bodilycavity or position the elongate members 304 in the vicinity of thetissue surface. In some embodiments, structure 308 has a size in theunexpanded or delivery configuration suitable for delivery through abodily opening (e.g., via catheter sheath 312) to the bodily cavity. Invarious embodiments, catheter sheath 312 typically includes a lengthsufficient to allow the catheter sheath to extend between a location atleast proximate a bodily cavity into which the structure 308 is to bedelivered and a location outside a body comprising the bodily cavity. Insome embodiments, structure 308 has a size in the expanded or deployedconfiguration too large for delivery through a bodily opening (e.g., viacatheter sheath 312) to the bodily cavity. The elongate members 304 mayform part of a flexible circuit structure (e.g., also known as aflexible printed circuit board (PCB) circuit). The elongate members 304can include a plurality of different material layers. Each of theelongate members 304 can include a plurality of different materiallayers. The structure 308 can include a shape memory material, forinstance Nitinol. The structure 308 can include a metallic material, forinstance stainless steel, or non-metallic material, for instancepolyimide, or both a metallic and non-metallic material by way ofnon-limiting example. The incorporation of a specific material intostructure 308 may be motivated by various factors including the specificrequirements of each of the unexpanded or delivery configuration andexpanded or deployed configuration, the required position or orientation(e.g., pose), or both of structure 308 in the bodily cavity or therequirements for successful ablation of a desired pattern.

FIG. 4 is a schematic side elevation view of at least a portion of atransducer-based device 400 that includes a flexible circuit structure401 that is employed to provide a plurality of transducers 406 (twocalled out) according to an example embodiment. In some embodiments, theflexible circuit structure 401 may form part of a structure (e.g.,structure 308) that is selectively movable between a deliveryconfiguration sized for percutaneous delivery and expanded or deployedconfigurations sized too large for percutaneous delivery. In someembodiments, the flexible circuit structure 401 may be located on, orform at least part of, a structural component (e.g., elongate member304) of a transducer-based device system.

The flexible circuit structure 401 can be formed by various techniquesincluding flexible printed circuit techniques. In some embodiments, theflexible circuit structure 401 includes various layers includingflexible layers 403 a, 403 b and 403 c (i.e., collectively flexiblelayers 403). In some embodiments, each of flexible layers 403 includesan electrical insulator material (e.g., polyimide). One or more of theflexible layers 403 can include a different material than another of theflexible layers 403. In some embodiments, the flexible circuit structure401 includes various electrically conductive layers 404 a, 404 b and 404c (collectively electrically conductive layers 404) that are interleavedwith the flexible layers 403. In some embodiments, each of theelectrically conductive layers 404 is patterned to form variouselectrically conductive elements. For example, electrically conductivelayer 404 a is patterned to form a respective electrode 415 of each ofthe transducers 406. Electrodes 415 have respective electrode edges415-1 that form a periphery of an electrically conductive surfaceassociated with the respective electrode 415. It is noted that otherelectrodes employed in other embodiments may have electrode edgesarranged to form different electrodes shapes (for example as shown byelectrode edges 315-1 in FIG. 3C).

Electrically conductive layer 404 b is patterned, in some embodiments,to form respective temperature sensors 408 for each of the transducers406 as well as various leads 410 a arranged to provide electrical energyto the temperature sensors 408. In some embodiments, each temperaturesensor 408 includes a patterned resistive member 409 (two called out)having a predetermined electrical resistance. In some embodiments, eachresistive member 409 includes a metal having relatively high electricalconductivity characteristics (e.g., copper). In some embodiments,electrically conductive layer 404 c is patterned to provide portions ofvarious leads 410 b arranged to provide an electrical communication pathto electrodes 415. In some embodiments, leads 410 b are arranged to passthough vias (not shown) in flexible layers 403 a and 403 b to connectwith electrodes 415. Although FIG. 4 shows flexible layer 403 c as beinga bottom-most layer, some embodiments may include one or more additionallayers underneath flexible layer 403 c, such as one or more structurallayers, such as a steel or composite layer. These one or more structurallayers, in some embodiments, are part of the flexible circuit structure401 and can be part of, e.g., elongate member 304. In some embodiments,the one or more structural layers may include at least one electricallyconductive surface (e.g., a metallic surface) exposed to blood flow. Inaddition, although FIG. 4 shows only three flexible layers 403 a-403 cand only three electrically conductive layers 404 a-404 c, it should benoted that other numbers of flexible layers, other numbers ofelectrically conductive layers, or both, can be included.

In some embodiments, electrodes 415 are employed to selectively deliverRF energy to various tissue structures within a bodily cavity (notshown) (e.g., an intra-cardiac cavity or chamber). The energy deliveredto the tissue structures may be sufficient for ablating portions of thetissue structures. The energy delivered to the tissue may be deliveredto cause monopolar tissue ablation, bipolar tissue ablation, or blendedmonopolar-bipolar tissue ablation by way of non-limiting example.

Energy that is sufficient for tissue ablation may be dependent uponfactors including transducer location, size, shape, relationship withrespect to another transducer or a bodily cavity, material or lackthereof between transducers, et cetera. For example, a pair ofelectrodes that each is approximately 10 mm² in surface area and presentalong a same structural member (e.g., an elongate member 304 in variousones of FIG. 3) may be expected, in some circumstances, to sufficientlyablate intra-cardiac tissue to a depth of approximately 3.1 mm with 2 Wof power and to a depth of approximately 4.4 mm with 4 W of power. Foryet another non-limiting example, if each electrode in this pair insteadhas approximately 20 mm² of surface area, it may be expected that suchpair of electrodes will sufficiently ablate intra-cardiac tissue to adepth of approximately 3.1 mm with 4 W of power and to a depth ofapproximately 4.4 mm with 8 W of power. In these non-limiting examples,power refers to the average power of each electrode summed together, andthe depth and power values may be different depending upon theparticular shapes of the respective electrodes, the particular distancebetween them, a degree of electrode-to-tissue contact, and otherfactors. It is understood, however, that for the same control or targettemperature, a larger electrode will achieve a given ablation depthsooner than a smaller electrode. A smaller electrode (e.g., an electrodewith a smaller surface area) may need to operate at a higher targettemperature to achieve the same ablation depth as compared to a larger(e.g., surface area) electrode (a phenomenon driven by a greaterdivergence of heat flux of smaller electrodes). Put differently, amaximum ablation depth (e.g., reached when the temperature profileapproaches steady state) of a relatively smaller electrode is typicallyshallower than that of a relatively larger electrode when ablating atthe same control or target temperature, and consequently, a given, lessthan maximum, ablation depth typically is a larger proportion of thefinal, maximum, ablation depth for a relatively smaller electrode andtypically is reached later in the ablation as compared to a relativelylarger electrode. This circumstance may be associated with a lower totalpower provided to the relatively smaller electrode as compared to arelatively larger electrode, but, nonetheless, the power density presentin the relatively smaller electrode may be expected to be somewhathigher as compared to the relatively larger electrode. The phrase “powerdensity” in this context means output power divided by electrode area.Note that power density approximately drives the realized control ortarget temperature, but in various cases, this is a simplification, andas indicated above, the relationship between power density and realizedcontrol or target temperature may be modified by such factors aselectrode size, shape, separation, and so forth. It is further notedthat when a comparison is made between a relatively larger electrodeoperated at a lower control temperature versus a relatively smallerelectrode operated at a higher temperature, further complications mayarise when limits on compensation for electrode size with temperatureare also dictated, at least in part, by a desire to reduce occurrencesof thermal coagulation of blood or steam formation in the ablatedtissue. It is noted that power levels in irrigated electrode systems aretypically higher (e.g., in the tens of Watts) than those describedabove.

In some embodiments, each electrode 415 is employed to sense or samplean electrical potential in the tissue proximate the electrode 415 at asame or different time than delivering energy sufficient for tissueablation. In some embodiments, each electrode 415 is employed to senseor sample intra-cardiac voltage data in the tissue proximate theelectrode 415. In some embodiments, each electrode 415 is employed tosense or sample data in the tissue proximate the electrode 415 fromwhich an electrogram (e.g., an intra-cardiac electrogram) may bederived. In some embodiments, each resistive member 409 is positionedadjacent a respective one of the electrodes 415. In some embodiments,each of the resistive members 409 is positioned in a stacked or layeredarray with a respective one of the electrodes 415 to form a respectiveone of the transducers 406. In some embodiments, the resistive members409 are connected in series to allow electrical current to pass throughall of the resistive members 409. In some embodiments, leads 410 a arearranged to allow for a sampling of electrical voltage in between eachresistive members 409. This arrangement allows for the electricalresistance of each resistive member 409 to be accurately measured. Theability to accurately measure the electrical resistance of eachresistive member 409 may be motivated by various reasons includingdetermining temperature values at locations at least proximate theresistive member 409 based at least on changes in the resistance causedby convective cooling effects (e.g., as provided by blood flow).

Referring to FIGS. 3A, 3B, 3C, and 3D transducer-based device 300 cancommunicate with, receive power from or be controlled by atransducer-activation system 322. In some embodiments, elongate members304 can form a portion of an elongated cable 316 of leads 317 (e.g.,control leads, data leads, power leads or any combination thereof), forexample by stacking multiple layers, and terminating at a connector 321or other interface with transducer-activation system 322. The leads 317may correspond to the electrical connectors 216 in FIG. 2 in someembodiments. The transducer-activation device system 322 may include acontroller 324 that includes a data processing device system 310 (e.g.,from FIG. 1) and a memory device system 330 (e.g., memory device system130 from FIG. 1) that stores data and instructions that are executableby the data processing device system 310 to process information receivedfrom transducer-based device 300 or to control operation oftransducer-based device 300, for example activating various selectedtransducers 306 to ablate tissue. Controller 324 may include one or morecontrollers.

Transducer-activation device system 322 includes an input-output devicesystem 320 (e.g., from FIG. 1) communicatively connected to the dataprocessing device system 310 (e.g., via controller 324 in someembodiments). Input-output device system 320 may include auser-activatable control that is responsive to a user action.Input-output device system 320 may include one or more user interfacesor input/output (I/O) devices, for example one or more display devicesystems 332, speaker device systems 334, one or more keyboards, one ormore mice (e.g., mouse 335), one or more joysticks, one or more trackpads, one or more touch screens or other transducers to transferinformation to, from, or both to and from a user, for example a careprovider such as a physician or technician. For example, output from amapping process may be displayed on a display device system 332.Input-output device system 320 may include one or more user interfacesor input/output (I/O) devices, for example one or more display devicesystems 332, speaker device systems 334, keyboards, mice, joysticks,track pads, touch screens or other transducers employed by a user toindicate a particular selection or series of selections of variousgraphical information. Input-output device system 320 may include asensing device system 325 configured to detect various characteristicsincluding, but not limited to, at least one of tissue characteristics(e.g., electrical characteristics such as tissue impedance, tissueconductivity, tissue type, tissue thickness) and thermal characteristicssuch as temperature. In this regard, the sensing device system 325 mayinclude one, some, or all of the transducers 306 (or 406 of FIG. 4) ofthe transducer based device 300, including the internal components ofsuch transducers shown in FIG. 4, such as the electrodes 415 andtemperature sensors 408.

Transducer-activation device system 322 may also include an energysource device system 340 including one or more energy source devicesconnected to transducers 306. In this regard, although various ones ofFIG. 3 show a communicative connection between the energy source devicesystem 340 and the controller 324 (and its data processing device system310), the energy source device system 340 may also be connected to thetransducers 306 via a communicative connection that is independent ofthe communicative connection with the controller 324 (and its dataprocessing device system 310). For example, the energy source devicesystem 340 may receive control signals via the communicative connectionwith the controller 324 (and its data processing device system 310),and, in response to such control signals, deliver energy to, receiveenergy from, or both deliver energy to and receive energy from one ormore of the transducers 306 via a communicative connection with suchtransducers 306 (e.g., via one or more communication lines throughcatheter body 314, elongated cable 316 or catheter sheath 312) that doesnot pass through the controller 324. In this regard, the energy sourcedevice system 340 may provide results of its delivering energy to,receiving energy from, or both delivering energy to and receiving energyfrom one or more of the transducers 306 to the controller 324 (and itsdata processing device system 310) via the communicative connectionbetween the energy source device system 340 and the controller 324.

In any event, the number of energy source devices in the energy sourcedevice system 340 is fewer than the number of transducers in someembodiments. The energy source device system 340 may, for example, beconnected to various selected transducers 306 to selectively provideenergy in the form of electrical current or power (e.g., RF energy),light or low temperature fluid to the various selected transducers 306to cause ablation of tissue. The energy source device system 340 may,for example, selectively provide energy in the form of electricalcurrent to various selected transducers 306 and measure a temperaturecharacteristic, an electrical characteristic, or both at a respectivelocation at least proximate each of the various transducers 306. Theenergy source device system 340 may include various electrical currentsources or electrical power sources as energy source devices. In someembodiments, an indifferent electrode 326 is provided to receive atleast a portion of the energy transmitted by at least some of thetransducers 306. Consequently, although not shown in various ones ofFIG. 3, the indifferent electrode 326 may be communicatively connectedto the energy source device system 340 via one or more communicationlines in some embodiments. In addition, although shown separately invarious ones of FIG. 3, indifferent electrode 326 may be considered partof the energy source device system 340 in some embodiments. In variousembodiments, indifferent electrode 326 is positioned on an externalsurface (e.g., a skin-based surface) of a body that comprises the bodilycavity into which at least transducers 306 are to be delivered.

It is understood that input-output device system 320 may include othersystems. In some embodiments, input-output device system 320 mayoptionally include energy source device system 340, transducer-baseddevice 300 or both energy source device system 340 and transducer-baseddevice 300 by way of non-limiting example. Input-output device system320 may include the memory device system 330 in some embodiments.

Structure 308 can be delivered and retrieved via a catheter member, forexample a catheter sheath 312. In some embodiments, a structure providesexpansion and contraction capabilities for a portion of the medicaldevice (e.g., an arrangement, distribution or array of transducers 306).The transducers 306 can form part of, be positioned or located on,mounted or otherwise carried on the structure and the structure may beconfigurable to be appropriately sized to slide within catheter sheath312 in order to be deployed percutaneously or intravascularly. FIGS. 3A,3B show one embodiment of such a structure. In some embodiments, each ofthe elongate members 304 includes a respective distal end 305 (only onecalled out in each of FIGS. 3A, 3B), a respective proximal end 307 (onlyone called out in each of FIGS. 3A, 3B) and an intermediate portion 309(only one called out in each of FIGS. 3A, 3B) positioned between theproximal end 307 and the distal end 305. The respective intermediateportion 309 of each elongate member 304 includes a first or frontsurface 318 a that is positionable to face an interior tissue surfacewithin a bodily cavity (not shown) and a second or back surface 318 bopposite across a thickness of the intermediate portion 309 from thefront surface 318 a. In some embodiments, each of the elongate members304 is arranged front surface 318 a-toward-back surface 318 b in astacked array during an unexpanded or delivery configuration similar tothat described in co-assigned International Application No.:PCT/US2012/022061 and co-assigned International Application No.:PCT/US2012/022062. In many cases a stacked array allows the structure308 to have a suitable size for percutaneous or intravascular delivery.In some embodiments, the elongate members 304 are arranged to beintroduced into a bodily cavity (again not shown) distal end 305 first.A flexible, elongated, catheter body 314 is used to deliver structure308 through catheter sheath 312 according to some embodiments.

In a manner similar to that described in co-assigned InternationalApplication No.: PCT/US2012/022061 and co-assigned InternationalApplication No.: PCT/US2012/022062, each of the elongate members 304 isarranged in a fanned arrangement 370 in FIGS. 3C, 3D. In someembodiments, the fanned arrangement 370 is formed during the expanded ordeployed configuration in which structure 308 is manipulated to have asize too large for percutaneous or intravascular delivery. In someembodiments, structure 308 includes a proximal portion 308 a having afirst domed shape 309 a and a distal portion 308 b having a second domedshape 309 b. In some embodiments, the proximal and the distal portions308 a, 308 b each include respective portions of elongate members 304.In some embodiments, the structure 308 is arranged to be delivereddistal portion 308 b first into a bodily cavity when the structure is inthe unexpanded or delivery configuration as shown in FIGS. 3A, 3B. Invarious embodiments, the proximal and distal portions 308 a, 308 b donot include a domed shape in the delivery configuration (for example, asshown in FIGS. 3A, 3B). In some embodiments, the first domed shape 309 aof the proximal portion 308 a and the second domed shape 309 b of thedistal portion 308 b are arranged in a clam shell configuration in theexpanded or deployed configuration shown in FIGS. 3C, 3D.

The transducers 306 can be arranged in various distributions orarrangements in various embodiments. In some embodiments, various onesof the transducers 306 are spaced apart from one another in a spacedapart distribution in the delivery configuration shown in FIGS. 3A, 3B.In some embodiments, various ones of the transducers 306 are arranged ina spaced apart distribution in the deployed configuration shown in FIGS.3C, 3D. In some embodiments, various pairs of transducers 306 are spacedapart with respect to one another. In some embodiments, various regionsof space are located between various pairs of the transducers 306. Forexample, in FIG. 3D the transducer-based device 300 includes at least afirst transducer 306 a, a second transducer 306 b, and a thirdtransducer 306 c (all collectively referred to as transducers 306). Insome embodiments each of the first, the second, and the thirdtransducers 306 a, 306 b, and 306 c are adjacent transducers in thespaced apart distribution. In some embodiments, the first and the secondtransducers 306 a, 306 b are located on different elongate members 304while the second and the third transducers 306 b, 306 c are located on asame elongate member 304. In some embodiments, a first region of space350 is between the first and the second transducers 306 a, 306 b. Invarious embodiments, a first region of space 350 is between therespective electrodes 315 a, 315 b of the first and the secondtransducers 306 a, 306 b. In some embodiments, the first region of space350 is not associated with any physical portion of structure 308. Insome embodiments, a second region of space 360 associated with aphysical portion of device 300 (e.g., a portion of an elongate member304) is between the second and the third transducers 306 b, 306 c. Invarious embodiments, the second region of space 360 is between therespective electrodes 315 b, 315 c of the second and the thirdtransducers 306 b, 306 c. In some embodiments, each of the first and thesecond regions of space 350, 360 does not include a transducer oftransducer-based device 300. In some embodiments, each of the first andthe second regions of space 350, 360 does not include any transducer. Itis noted that other embodiments need not employ a group of elongatemembers 304 as employed in the illustrated embodiment. For example,other embodiments may employ a structure having a one or more surfaces,at least a portion of the one or more surfaces defining one or moreopenings in the structure. In these embodiments, a region of space notassociated with any physical portion of the structure may extend over atleast part of an opening of the one or more openings.

In some embodiments, a first transducer set (e.g., a first set includingone or more of transducers 306) is arranged (e.g., axially,circumferentially, or both axially and circumferentially arranged)along, across, or over a portion of catheter body 314 while a second set(e.g., a second set including one or more of transducers 306) is locatedon structure 308 extending outwardly from a distal end 314 a of catheterbody 314. An example first transducer set 380 and example secondtransducer set 382 are shown in FIG. 3C according to some embodiments.In various example embodiments, transducer-based device 300 includes afirst transducer set (e.g., first transducer set 380) located proximallyof a distal end 314 a of catheter body 314 while a second transducer set(e.g., second transducer set 382) is located on structure 308 extendingoutwardly from the distal end 314 a of catheter body 314 (which isbetter seen in FIG. 3B). In some of these various example embodiments,structure 308 is selectively movable between a delivery configuration(e.g., FIGS. 3A, 3B) in which the first transducer set 380 and thesecond transducer set 382 are concurrently arranged in respectivearrangements sized for movement through a lumen of catheter sheath 312,and an expanded or deployed configuration (e.g., FIGS. 3C, 3D) in whichthe second transducer set 382 is arranged in a respective arrangementsized too large for delivery through the lumen of catheter sheath 312while the first transducer set 380 is arranged in a respectivearrangement sized for movement through the lumen of the catheter sheath312. For example, in some embodiments of the expanded or deployedconfiguration, each of various transducers 306 in the first transducerset 380 is movable inwardly into or outwardly from the lumen of cathetersheath 312 while the transducers 306 in the second transducer set 382are arranged in an arrangement too large for movement inwardly into thelumen of the catheter sheath 312. Advantageously, these embodiments mayallow particular transducers (e.g., transducers 306 in the firsttransducer set 380 to be introduced into or removed from a bodily cavitywhen the structure 308 is repositioned in the bodily cavity in theexpanded or deployed configuration. Repositioning of the structure 308in the bodily cavity may be required due to variances in a size of thecavity (e.g., a larger than expected size) or variances in an expectedpositioning of various anatomical landmarks. In either case, additionaltransducers 306 may be brought into play or out of play as the specificcircumstance may require. Bringing a particular transducer 306 into playwithin a bodily cavity may include appropriately positioning thetransducer for a desired sensing function, an energy transmissionfunction, or a sensing and energy transmission function within thebodily cavity.

In FIG. 3C, structure 308 includes an at least one elongate member 304 a(also shown in FIG. 3A) according to some embodiments. At least oneelongate member 304 a is sized and arranged to position at least some ofa first set of the transducers 306 (e.g., first transducer set 380)diametrically opposite from a portion 314 b (best seen in FIG. 3B) of anouter surface of catheter body 314, the portion of the outer surface notincluding any transducer. In some example embodiments, portion 314 bincludes at least a semicircular portion of an outer surface of catheterbody 314. In some embodiments, various ones of the elongate members 304of structure 308 extend outwardly away from the distal end 314 a of thecatheter body 314 while at least one elongate member 304 (e.g., at leastone elongate member 304 a) extends outwardly from a location (e.g.,location 314 c) on the catheter body 314 spaced proximally inward fromthe distal end 314 a of the catheter body 314. In some embodiments, oneor more transducers 306 of the first transducer set 380 are locatedwithin a region of space between location 314 c and distal end 314 a. Insome embodiments, elongate member 304 a is sized and arranged toposition first transducer set 380 along the catheter body 314 inwardlyfrom the distal end 314 a of the catheter body 314 while positioning athird transducer set 384 outwardly from the distal end 314 a of catheterbody 314, each of the first and the third transducer sets 380, 384located on elongate member 304 a. In some embodiments, elongate member304 a is sized and arranged to position at least some of transducers 306over a twisted region 311 of each of at least some of the other elongatemembers 304. In some embodiments, respective portions of each of atleast three of the elongate members 304 are arranged front surface 318a-toward-back surface 318 b along a first direction (for exampleindicated by arrow 318 in FIG. 3A) to form a stacked array in thedelivery configuration (e.g., FIG. 3A), and at least one portion of therespective front surface 318 a of at least one elongate member 304 a isarranged to face in a direction (e.g., represented by arrow 319 in FIG.3A) other than the first direction in the delivery configuration. Inother example embodiments, other structures may be employed to supportor carry transducers of a transducer-based device such as atransducer-based catheter. For example, an elongated catheter member maybe used to distribute the transducers in a linear or curvilinear array.Basket catheters or balloon catheters may be used to distribute thetransducers in a two-dimensional or three-dimensional array.

FIGS. 6A-6F include respective data generation and flow diagrams, whichmay implement various embodiments of method 600 by way of associatedcomputer-executable instructions according to some example embodiments.In various example embodiments, a memory device system (e.g., memorydevice systems 130, 330) is communicatively connected to a dataprocessing device system (e.g., data processing device systems 110 or310, otherwise stated herein as “e.g., 110, 310”) and stores a programexecutable by the data processing device system to cause the dataprocessing device system to execute various embodiments of method 600via interaction with at least, for example, a transducer-based device(e.g., transducer-based devices 200, 300, or 400). In these variousembodiments, the program may include instructions configured to perform,or cause to be performed, various ones of the instructions associatedwith execution of various embodiments of method 600. In someembodiments, method 600 may include a subset of the associated blocks oradditional blocks than those shown in FIGS. 6A-6F. In some embodiments,method 600 may include a different sequence indicated between variousones of the associated blocks shown in FIGS. 6A-6F.

In some embodiments, block 604 is associated with computer-executableinstructions (e.g., graphical representation instructions or graphicalinterface instructions or display instructions provided by a program)configured to cause an input-output device system (e.g., input-outputdevice system 120 or 320) to display a graphical representation. FIG. 5Aillustrates a graphical interface including a graphical representation500 provided by the input-output device system according to one exampleembodiment provided in accordance with display instructions associatedwith block 604 in FIG. 6A. In some embodiments, the graphicalrepresentation 500 includes a three-dimensional graphical representationof at least a portion of a transducer-based device (e.g., structure 308in FIG. 3) and is provided in accordance with the computer-executableprogram instructions associated with block 606. The instructionsassociated with block 606 may be configured to access a predefined model(e.g., a computer-aided-design (“CAD”) or other computer-readable modelstored in memory device system 130, 330) of the at least the portion ofthe transducer-based device and display the at least the portion of thetransducer-based device according to such model. In some embodimentsencompassing FIG. 5A, the representation of the transducer-based deviceis provided by or among various elements of graphical representation500. In some embodiments, the graphical interface depicts thetransducer-based device as including a first domed portion 508 aassociated with a first domed portion of the transducer-based device(e.g., proximal portion 308 a when having the first domed shape 309 a)and a second domed portion 508 b associated with a second domed portionof the transducer-based device (e.g., distal portion 308 b having thesecond domed shape 309 b). A separation graphical element 503 may beemployed between the first and the second domed portions 508 a, 508 b insome embodiments, but may be omitted in other embodiments. Various othertransducer-based devices may be depicted according to the instructionsassociated with block 606 in other embodiments. FIGS. 5A, 5B, 5C, 5D,5E, 5F, 5G, 5H, 5I, 5J, 5K, 5J, 5L, and 5M (collectively FIG. 5) arepresented in this disclosure in association with various embodiments. Itis understood that each of these embodiments need not be associated withall of the FIG. 5, and in some cases will only be associated with asubset of the FIG. 5.

In some embodiments according to FIG. 5A, a plurality of graphicalelements 501 (only two called out) are depicted (e.g., according to theinstructions associated with block 606) among various elements ofgraphical representation 500. In various embodiments, each of thegraphical elements 501 is respectively associated with a respective oneof a plurality of transducer sets. Each respective transducer setincludes at least one of a plurality of transducers included as part ofthe transducer-based device (e.g., transducer-based devices 200, 300, or400) and each respective transducer set has at least one differenttransducer than another of the other transducer sets. In variousparticular embodiments, each respective transducer set has at least onedifferent transducer than each of the other transducer sets.

FIG. 5B shows the graphical interface in which the display instructionshave been configured to cause (for example, in response to a user inputvia an input-output device system such as 120, 320) thethree-dimensional graphical representation of the transducer-baseddevice to be manipulated so as to be viewed from a different viewingangle than that shown in FIG. 5A. In some embodiments, the depiction ofthe transducer-base device may include various other elements thereof.For example, FIG. 5B depicts the transducer-based device as including anelongated portion 500 c (e.g., extending from or toward domed portion508 a in some embodiments). In various embodiments, elongated portion500 c is representative of a particular element that is the same orsimilar to at least one elongate member 304 a in various ones of FIG.3B. It is noted that three-dimensional representations of at leastportion of the transducer-based device are shown in FIGS. 5A, 5B, 5C, 5Dand 5L.

Referring to some embodiments encompassing FIG. 5A , each of at leastsome of the graphical elements 501 is provided by a respective one of aplurality of transducer graphical elements 502 that include at least afirst transducer graphical element 502 a, a second transducer graphicalelement 502 b, and a third transducer graphical element 502 c (e.g., allthe transducer graphical elements forming part of a group of transducergraphical elements 502). In some embodiments, each transducer graphicalelement 502 is associated with a single respective transducer of thetransducer-based device. In some example embodiments, each transducergraphical element 502 is representative of a respective transducer ofthe transducer-based device. In some example embodiments, eachtransducer graphical element 502 is representative of a location orposition of a respective transducer of the transducer-based device. Insome embodiments, the graphical representation 500 includes a firstspatial relationship between the transducer graphical elements 502 thatis consistent with a second spatial relationship between thecorresponding transducers associated with the transducer graphicalelements 502. For example, in some embodiments, the transducer graphicalelements 502 in the three dimensional graphical representation 500 inFIGS. 5A, 5B may exhibit a same spatial relationship that thetransducers 309 exhibit in the transducer based device 300 in FIG. 3C.Or, in some embodiments, the transducer graphical elements 502 in othergraphical representations 500 in others of FIG. 5 may exhibit arespective or corresponding spatial relationship that the transducers309 exhibit in the transducer based device 300 in FIGS. 3C and 3D. Inthis regard, in some embodiments, the graphical representation 500 mayinclude a first spatial relationship between the transducer graphicalelements 502 that is consistent with a second spatial relationshipbetween the corresponding transducers associated with the transducergraphical elements 502 when the corresponding transducers are arrangedin a deployed configuration (e.g., FIGS. 3C, 3D). In some embodiments,each particular depicted transducer graphical element 502 is shownhaving a shape that is consistent with the particular transducer (orportion thereof) that the particular transducer graphical element 502 isrepresentative of. For example, in FIG. 5A, transducer graphical element502 d includes an essentially square shape with rounded corners that isconsistent with the square, rounder cornered shape of the electrode 315d of transducer 306 d shown in FIG. 3D. Additionally, in FIG. 5A,transducer graphical element 502 e includes an essentially triangularshape with rounded corners that is consistent with the triangular,rounded cornered shape of the electrode of transducer 306 e shown inFIG. 3D. Further, in FIG. 5A, transducer graphical element 502 fincludes an essentially oval shape that is consistent with the ovalshape of the electrode 315 f of transducer 306 f shown in FIG. 3D.Others transducer graphical elements 502 in FIGS. 5A and 5B have shapesthat are consistent with respective ones of the electrodes shown inFIGS. 3C and 3D. A graphical representation 523 of an electrocardiogram(ECG/EKG) signal 523 is also shown in the graphical interface of variousones of FIG. 5.

In some example embodiments, graphical elements 501 may includealternate or additional forms. For example FIG. 5C shows an exampleembodiment in which each of at least some of the graphical elements 501are provided by a respective one of a plurality of between graphicalelements 504 including a first between graphical element 504 a and asecond between graphical element 504 b (e.g., all the between graphicalelements collectively referred to as between graphical elements 504).FIG. 5D shows an embodiment of the graphical interface in which thedisplay instructions have been configured to cause (for example, inresponse to a user input via an input-output device system such as 120,320) the depiction of the transducer-based device to manipulated so asto be viewed from a different viewing angle than that shown in FIG. 5C.In some embodiments, between graphical elements 504 are shown inaddition to various ones of the transducer graphical 502 shown in FIGS.5A and 5B. In some embodiments, between graphical elements 504 areprovided separately or with other embodiments of graphical elements 501.In various embodiments, each of the between graphical elements 504 isassociated with a set of at least two (e.g., a group) of the transducersof the transducer-based device. In some example embodiments, each of thebetween graphical elements 504 is associated with a pair of transducersin the transducer-based device. In some example embodiments, eachbetween graphical element 504 is associated with a region of spacebetween a respective pair of transducers in the transducer-based device.In some example embodiments, each between graphical element 504 isassociated with a region of space between a respective pair of adjacentones of the transducers in the transducer-based device.

In some embodiments, first transducer graphical element 502 a isassociated with a first transducer (e.g., first transducer 306 a) of thetransducer-based device, second transducer graphical element 502 bassociated with a second transducer (e.g., second transducer 306 b) ofthe transducer-based device, and third transducer graphical element 502c associated with a third transducer (e.g., third transducer 306 c) ofthe transducer-based device. In some embodiments, each of the transducergraphical elements 502 a, 502 b and 502 c has a shape that is consistentwith a shape of the respective electrode 315 a, 315 b, 351 c of thecorresponding one of the transducers 306 a, 306 b and 306 c. In someembodiments, the first between graphical element 504 a is associatedwith a first region of space that is between the first and the secondtransducers and the second between graphical element 504 b is associatedwith a second region of space that is between the second and the thirdtransducers. In some embodiments, the first region of space is a regionof space that is not associated with any physical part of thetransducer-based device (e.g., first region of space 350) and the secondregion of space is a region of space that is associated with a physicalpart of the transducer-based device (e.g., second region of space 360).In some embodiments, each of the first and the second between graphicalelements 504 a, 504 b is associated with a region of space that does notinclude a transducer of the transducer-based device. In someembodiments, each of the first and the second between graphical elements504 a, 504 b is associated with a region of space that does not includeany transducer. It is understood that a “region of space” need not be avacant space but can include physical matter therein.

In some embodiments, the first between graphical element 504 a ispositioned between the second and the first transducer graphicalelements 502 b, 502 a among the graphical representation 500. In someembodiments, the second between graphical element 504 b is positionedbetween the second and the third transducer graphical elements 502 b,502 c among the graphical representation 500. In other exampleembodiments, other spatial relationships exist between the transducergraphical elements 502 and the between graphical elements 504 in thegraphical representation.

The transducer graphical elements 502, the between graphical elements504, or both may have different sizes, shapes or forms than those shownin the illustrated embodiment.

In some embodiments, at least one particular one of the transducergraphical elements 502 may be depicted with a different shape, size, orform than the respective one of the shape, size or form of therespective portion of the particular transducer to which the particularone of the transducer graphical elements 502 corresponds. In someembodiments, different ones of the between graphical elements 504 may bedepicted with different shapes, sizes, or forms.

With reference to various ones of FIG. 5, at least a portion of thetransducer graphical elements 502, and at least a portion of the betweengraphical elements 504 are arranged in a plurality of rows 510 (twocalled out in FIG. 5A) and a plurality of columns 512 (two called out inFIG. 5A). In some embodiments, each row corresponds to a respective oneof number “0”, “1”, “2”, “3”, “4”, “5”, “6”, “7”, “8”, “9”, “10”, and“11”, and each column 512 corresponds to a respective one of letters“A”, “B”, “C”, “D”, “E”, “F”, “G”, “H”, “I”, “J”, “K”, “L”, “N”, “O”,“P”, “Q”, “R”, “S”, and “T”, each of the numbers and letters used aspart of the unique identifier 513 (only two called out with referencenumeral 513 in FIG. 5A) of each transducer graphical element 504. Insome embodiments, the plurality of rows 510 and columns 512 correspondto condition in which structure 308 is in the deployed configuration. Insome embodiments, a portion of each of the columns 512 corresponds toregion of space associated with a physical portion of thetransducer-based device (e.g., an elongate member 304). In someembodiments, each of the columns 512 corresponds to at least a portionof the transducers located on a particular elongate member of atransducer-based device (e.g., an elongate member 304). In someembodiments, at least one of the columns 512 includes at least onetransducer graphical element 502 having a shape that is different thanthe respective shape comprised by any of the transducer graphicalelements 502 included in at least one other of the columns 512. Forexample, the “A” column 512 includes a transducer graphical element 502identified as “A:10” that has a shape that is different than any of thetransducer graphical elements 502 comprised by at least one of the othercolumns 512. In some embodiments, at least a first one of the rows 510includes identically shaped transducer graphical elements 502 (e.g., row510 that includes transducer graphical elements 502 identified as “A:6”,“B:6”, “C:6”, “D:6”, “E:6”, “F:6”, “G:6”, “H:6”, “I:6”, “J6”, “K:6”,“L:6”, “M:6”, “N:6”, “O:6”, “P:6”, “Q:6”, “R:6”, “S:6” and “T:6”), andat least a second one of the rows 510 includes differently shapedtransducer graphical elements 502 (e.g., row 510 that includestransducer graphical elements 502 identified as “A:10”, “B:10”, “C:10”,“D:10”, “E:10”, “F:10”, “G:10”, “H:10”, “I:10”, “K:10”, “L:10”, “M:10”,“N:10”, “O:10”, “P:10”, “Q:10”, “R:10”, and “S:10”). In some exampleembodiments, a portion of each of the rows 510 corresponds to regions ofspace not associated with any physical portion of the transducer-baseddevice (e.g., regions of space 350 between adjacent ones of the elongatemembers 304). In other example embodiments, different numbers oftransducer graphical elements 502 and different numbers and spatialarrangements of between graphical elements 504 may be depicted in thegraphical representation. In other example embodiments, differentnumbers and spatial arrangements of rows 510 and columns 512 may bedepicted in the graphical representation. In various embodiments, eachof the between graphical elements (e.g., between graphical elements 504)depicted in the graphical representation are representative of arespective physical path extending between a respective pair oftransducers of the transducer-based device. Each of the physical pathsmay extend over a physical surface of the transducer-based device orover a portion of an opening defined by a physical surface of thetransducer-based device. In the embodiment shown in FIG. 5C, eachbetween graphical element 504 is representative of a respective physicalpath extending between the respective transducers associated with theadjacent pair of transducer graphical elements 502 that the betweengraphical element 504 extends between. In the embodiment shown in FIG.5C, each adjacent pair of the transducer graphical elements 502 may beprovided along a row 510 (two called out in FIG. 5C) of the graphicalelements 501, along a column 512 (two called out in FIG. 5C) of thegraphical elements 501, or diagonally between a row 510 and a column512.

Referring back to FIGS. 5A, 5B, the plurality of rows 510 and theplurality of columns 512 are depicted as a three-dimensional arrangementin the graphical representation. In some embodiments, at least two ofthe plurality of columns 512 are depicted in the graphicalrepresentation extending along respective directions that converge withrespect to one another. In some embodiments, at least two of theplurality of columns 512 are depicted in the graphical representationextending along non-parallel directions and at least two of theplurality of rows 510 is depicted extending along parallel directions.In some embodiments, the rows 510 and the columns 512 are depicted inthe graphical representation in an arrangement in which the columns 512are circumferentially arranged. In some embodiments, the rows 510 andthe columns 512 are depicted in the graphical representation in anarrangement having a generally spherical shape. The plurality of columns512 may be depicted like lines of longitude, and the plurality of rows510 may be depicted like lines of latitude. Although the rows 510 andcolumns 512 are illustrated in FIGS. 5A-5D as circumferential lines(like lines of longitude and latitude), such rows 510 and columns 512can take other forms, as shown, for example, in FIGS. 5E and 5F,discussed in more detail below, according to some embodiments.

The display instructions (e.g., according to block 604, 606, or both)may include instructions (e.g., instructions responsive to a user inputmade via an input-output device system) configured to vary the depictionof the portion of the transducer-based device between athree-dimensional representation (e.g., as depicted in various ones ofFIGS. 5A, 5B, 5C, and 5D) and a two dimensional representation (e.g., asdepicted by FIG. 5E or 5F). Various two-dimensional representations arepossible in various embodiments. For example, the two-dimensionalrepresentation depicted in FIG. 5E may be generated according to thedisplay instructions according to a Mercator projection or otherthree-dimensional-to-two-dimensional projection, known in the art,according to some embodiments. In other embodiments, the two-dimensionalrepresentation need not be a projection from a three-dimensional model,and may merely be any two-dimensional representation, e.g., including anarrangement of transducers.

The two-dimensional representation depicted in FIG. 5E, according tosome embodiments, represents the first domed portion 500 a (e.g., shownin FIGS. 5C, 5D) of the depicted transducer-based device as firstMercator projection 518 a and the second domed portion 500 b (e.g.,shown in FIGS. 5C, 5D) of the depicted transducer-based device as asecond Mercator projection 518 b. The first and the second Mercatorprojections 518 a and 518 b advantageously allow for simultaneousviewing of all the transducer graphical elements 502 and the betweengraphical elements 504. Columns 512 and rows 510 are depictedtwo-dimensionally in FIG. 5E. In some embodiments, separation element513 is also depicted in a two-dimensional configuration.

As discussed above, other two-dimensional representations may beimplemented and may be user-selectable for viewing. For example, FIG. 5Fillustrates a transverse Mercator projection employed according to someembodiments. In FIG. 5F, the transverse Mercator projection includes twoportions 518 c, 518 d, each of the portions 518 c, 518 d representativeof a respective one of first and second domed portions 500 a and 500 bin the corresponding three-dimensional representation. In FIG. 5F,portion 518 d of the transverse Mercator projection is shown as twoparts, each part at least depicting the transducer graphical elements502 in a respective one of two parts of the domed portion 508 b. In FIG.5F, portion 518 c is representative of first domed portion 508 a. Insome embodiments, various ones of the columns 512 radiate outwardlyradially or quasi-radially from particular ones of a plurality of poleregions 511 a and 511 b represented in the graphical representation 500.In some embodiments, various ones of the rows 510 are circumferentiallyarranged about particular ones of a plurality of pole regions 511 a and511 b.

In some embodiments, at least some of the between graphical elements 504are not shown in various ones of the displayable two-dimensionalrepresentations. For example, in FIG. 5F, between graphical elements 504have been selectively controlled, e.g., in response to user input, notto be visible among the graphical representation. In variousembodiments, the transducer graphical elements 502 shown in each of theFIGS. 5E and 5F are arranged with respect to one another according to aspatial relationship that corresponds to a spatial relationship that thetransducer graphical elements are arranged in the three-dimensionalrepresentations shown in various ones of FIGS. 5A, 5B, 5C, 5D and 5L. Invarious embodiments, the transducer graphical elements 502 shown in eachof the FIGS. 5E and 5F are arranged with respect to one anotheraccording to a spatial relationship that corresponds to a spatialrelationship that particular transducers that the transducer graphicalelements 502 correspond to, are arranged with respect to one anotherwhen a supporting structure (e.g., structure 308) is in a deployedconfiguration.

Various computer-executable instructions may be configured to controlvarious input element control functions (e.g., mouse drag functions,touch screen drag functions) between various operating modes such asrotating and panning modes. A rotating mode may be advantageously usedfor manipulation of a three-dimensional representation of atransducer-based device or other portions of the graphicalrepresentation 500 to allow for viewing one or more portions of thethree-dimensional representation of the transducer-based device orvarious portions of the graphical representation 500 that were notpreviously viewable (e.g., a manipulation between the views shown inFIGS. 5A and 5B or a manipulation between the views shown in FIGS. 5Cand 5D). In some embodiments, a panning mode may be advantageously usedfor manipulation of a two-dimensional representation of thetransducer-based device or other portions of the graphicalrepresentation 500 to allow for viewing of different arrangements ofvarious graphical elements in the representation of a transducer-baseddevice or other portions of the graphical representation 500. Forexample, in FIG. 5F, an up-down panning manipulation (e.g., caused inresponse to a mouse drag or touch screen drag function) may adjust asize of each of the portions 518 d that are representative of domedportion 508 b (e.g., one of the portions 518 d increasing in size whilethe other portion 518 d decreases in size) or in some cases combine theplurality of portions 518 d into a fewer number of portions (e.g., asingle portion 518 d), or in some cases divide portion 518 crepresentative of the first domed portion 508 a into a plurality ofportions 518 c.

In some embodiments, a rotating mode may be advantageously used formanipulation of a two-dimensional representation of the transducer-baseddevice or other portions of the graphical representation 500 to allowfor viewing of different arrangements of various graphical elements inthe transducer-based device or other portions of the graphicalrepresentation 500. For example, in FIG. 5F, a rotation mode (forexample, caused in response to a mouse drag or touch screen dragfunction) may be employed to rotate or revolve various ones of thetransducer graphical elements 502 or other elements of the graphicalrepresentation 500 about a selected one of two pole regions 511 a and511 b. It is noted in some embodiments, a particular rotation of a firstset of graphical elements about one of the pole regions 511 a and 511 bin a first particular rotational direction (e.g., a clockwise direction)may be automatically accompanied by a particular rotation of a secondset of graphical elements about the other of the pole regions 511 a and511 b in second particular rotation direction different than the firstparticular rotational direction (e.g., a counterclockwise direction).

It is noted that, even though an entirety of the representation of thetransducer-based device may be shown in the two-dimensionalrepresentation, various panning or rotation modes such as describedabove may be employed to position various ones of the displayedgraphical elements in a configuration that may provide a betterunderstanding of a particular relationship between the graphicalelements. For example, in some embodiments, the transducer graphicalelements 502 k and 502 l respectively identified as “P:5” and “P:6” inFIG. 5F correspond to an adjacent pair of transducers, but are displayedapart from one another in the two portions 518 b. A rotation (forexample as described above) about one of the two pole regions 511 a, 511b may be used to position the transducer graphical elements 502 k and502 l respectively identified as “P:5” and “P:6” closer together, forexample in the medial region 511 c to better convey informationdescribing the adjacency of the transducers corresponding to thetransducer graphical elements 502 k and 502 l. In some exampleembodiments, a rotation (for example as described above) about one ofthe two pole regions 511 a, 511 b may be used to position the transducergraphical elements 502 k and 502 l adjacently together without anyothers of the transducer graphical elements 502 positioned therebetween.

In some embodiments, the respective transducers of the adjacent pair oftransducers (e.g., an adjacent pair of transducers 306) corresponding totransducer graphical elements 502 k and 502 l are located a samestructural member (e.g., a same one of elongate members 304). In someembodiments, a region of space that includes a physical portion of thetransducer-based device is located between the respective transducers ofthe adjacent pair of transducers (e.g., an adjacent pair of transducers306) corresponding to transducer graphical elements 502 k and 502 l. Invarious embodiments, the rotation mode synchronizes rotation about oneof the pole regions 511 a, 511 b with the rotation about the other ofthe pole regions 511 a, 511 b such that various transducer graphicalelements 502 representative of an adjacent pair of transducers maintaina spatial relationship when rotated into the medial region 511 c that isconsistent with the spatial relationship of the corresponding adjacenttransducers. In FIG. 5F, various columns of adjacent transducergraphical elements 502 radially extend or converge towards each of thepole regions 511 a and 511 b. The synchronized rotation about one of thepole regions 511 a, 511 b with the rotation about the other of the poleregions 511 a, 511 b allows each of the columns to continue to radiallyextend or converge towards each of the pole regions 511 a and 511 b atleast while the columns are positioned in portion 518 c

In some embodiments, various ones of these manipulation modes may allowthe user to better understand a relationship or interaction between thetransducer graphical elements 502 and any displayed physiologicalinformation (e.g., intra-cardiac information) displayed in the graphicalrepresentation (e.g., as described below at least with respect to FIGS.5G-5M). In some embodiments, various ones of these manipulation modesmay allow the user to better understand a relationship of various onesof the transducers corresponding to various ones of the transducergraphical elements to facilitate a selection or non-selection thereof.It is noted that various ones of the manipulations modes are not limitedto the two-dimensional representation of FIG. 5F and may be employedwith other forms of two-dimensional representations. For example, insome embodiments, the transducer graphical elements 502 m and 502 nrespectively identified as “T:5” and “A:5” in FIG. 5E correspond to anadjacent pair of transducers (e.g., an adjacent pair of transducers306), but are displayed apart from one another. An up-down panningmanipulation (for example as described above) may be employed to bettervisualize the adjacency of the transducers corresponding to thetransducer graphical elements 502 m and 502 n respectively identified as“T:5” and “A:5”. In some embodiments, the respective transducers of theadjacent pair of transducers (e.g., an adjacent pair of transducers 306)corresponding to transducer graphical elements 502 m and 502 n arelocated on different structural members (e.g., different or separateones of elongate members 304). In some embodiments, a region of spacethat does not include any physical portion of the transducer-baseddevice is located between the respective transducers of the adjacentpair of transducers (e.g., an adjacent pair of transducers 306)corresponding to transducer graphical elements 502 m and 502 n.

A Mercator projection such as that employed in embodiments associatedwith FIG. 5E may include various distortions in some of the elements(e.g., transducer graphical elements 504) at least proximate theboundary regions 517 a, 517 b of the projection. In some embodiments,the columns 512 of graphical elements 512 act like converging lines oflongitude in a three-dimensional representation (e.g., FIGS. 5A, 5B, 5Cand 5D) and the distortions at least proximate the boundary regions 517a, 517 b may be provided to account or compensate for the convergence ofcolumns 512. It is noted, however, that a panning mode (e.g., aleft-right panning mode) that may move one of the boundary regions 517a, 517 b inwardly or centrally within the graphical representation may,in some embodiments, maintain the distortions in the various graphicalregions that occupy or move along with the moved one of the boundaryregions 517 a, 517 b. Moving these distorted regions inwardly orcentrally within the field of view of the user may not provide, in somecases, a readably understandable representation of various facets ofthese graphical elements (e.g., a spatial relationship therebetween).The two-dimensional representation depicted in FIG. 5F, on the otherhand, centralizes the graphical elements (e.g., transducer graphicalelements 502) that are located in the boundary regions 517 a, 517 b ofFIG. 5F centrally proximate the pole regions 511 a, 511 b of FIG. 5Fwith reduced levels of distortions. In this regard, the graphicalrepresentation of FIG. 5F provides a good understanding of the variousrelationships (e.g., spatial relationships) associated with “pole” areas(e.g., areas where the columns 312 converge like lines of longitude) ofthe corresponding three-dimensional representation. On the other hand,the graphical representation of FIG. 5E provides a good understanding ofthe various relationships (e.g., spatial relationships) associated with“equatorial areas (e.g., equatorial regions of columns 312 when actinglike lines of longitude) of the corresponding three-dimensionalrepresentation. In some embodiments, two or more differenttwo-dimensional representations are concurrently displayed via aninput-output device system (e.g., 120, 320). In some embodiments, bothof the two-dimensional representations shown in FIGS. 5E and 5F areconcurrently displayed via an input-output device system (e.g., 120,320).

In each of the FIGS. 5E and 5F, each of the transducer graphicalelements 502 has a respective shape that is the same, or generally thesame as, a shape of at least a portion of a corresponding transducer(e.g., transducer 306) that the transducer graphical element represents.In some embodiments, each of the transducer graphical elements 502 has arespective shape that is the same, or generally the same, as shape of anelectrode (e.g., electrode 315) of a corresponding transducer (e.g.,transducer 306) that the transducer graphical element represents. Ineach of the FIGS. 5E and 5F, the shape of each of at least some of thetransducer graphical elements 502 is distorted and deviates in someaspects from the respective shape of a corresponding electrode. Unlike adistortion caused by the use of “perspective” (e.g., a varying of anappearance of objects in respect to their perceived relative distanceand positions) in corresponding three-dimensional representations (e.g.,FIGS. 5A, 5B, 5C, 5D), various graphical elements in FIGS. 5E and 5Femploy other forms of distortion (for example, as described above inthis description). For example, in FIG. 5F, increased levels ofdistortions (e.g., increased sizes or dimensions, increased stretching)accompany various ones of the transducer graphical elements 502 that areincreasingly spaced from pole regions 511 a and 511 b. In FIG. 5E,increased levels of distortions (e.g., increased sizes or dimensions,increased stretching) accompany various ones of the transducer graphicalelements 502 that are spaced relatively close to the boundary regions517 a, 517 b as compared with various ones of the transducer graphicalelements that are located relatively far from the boundary regions 517a, 517 b. In either case, and unlike the perspective-based distortionsemployed in some three-dimensional representations, some of the morehighly distorted transducer graphical elements 504 include enlargedshapes (e.g., relative to less distorted graphical elements 502displayed centrally in each of two-dimensional representations) andcorrespond to transducers that would be spaced relatively farther from aviewer (e.g., with the less distorted transducer graphical elements 502corresponding to transducers that would be spaced relatively closer tothe viewer).

In some embodiments associated with FIG. 5F, a rotation mode may beemployed to rotate at least some of the transducer graphical elements502 about one of the pole regions 511 a and 511 b and changes in theshape or size of various ones of transducer graphical elements 502during the rotation may occur. In some embodiments associated with FIG.5F, a rotation mode may be employed to rotate at least some of thetransducer graphical elements 502 about one of the pole regions 511 aand 511 b to vary a level of distortion comprised by various ones oftransducer graphical elements 502. For example, the transducer graphicalelement 502 o identified as “A:6” may, in some embodiments, be rotatedabout pole region 511 b with its size or level distortion reducing as itrotates toward medial region 511 c.

Referring back to FIG. 6A, the computer-executable display instructionsassociated with block 604 may include, in some embodiments, variousinstructions configured to allow for variations in the viewable contentof the graphical representation. The computer-executable displayinstructions associated with block 604 may include various instructions(e.g., computer-executable instructions associated with block 606)configured to allow for selective inclusions of the transducer graphicalelements 502 and the selective inclusion of the between graphicalelements 504 among the graphical representation 500. (In this regard,although block 606 is shown separately from block 604, block 606 may bea particular implementation of block 604 and such block may be combinedinto a single block.) In some example embodiments, the displayinstructions associated with block 606 may include instructions thatallow for the selective inclusion of identification labels 513 thatidentify various ones of the transducer graphical elements 502. Invarious example embodiments, each of the identification labels 513employs an alpha-numeric format including a letter representative of thecolumn 512 in which a corresponding transducer graphical element islocated and a number representative of a location of the transducergraphical element 502 in the corresponding column 514. Otheridentification schemes may be employed in other embodiments.

Having discussed embodiments associated with blocks 604 and 606 in FIG.6A, a discussion will now begin regarding embodiments where block 604follows block 602. (Recall that block 606 may be included within block604 and the arrow from block 602 to 604 may also point toward block 606,in some embodiments.) Block 602, in some embodiments, is associated withinstructions (e.g., input instructions included in a program) that causethe data processing device system (e.g., data processing device systems110 or 310) to acquire or receive intra-cardiac information.Intra-cardiac information can take various forms, including, but notlimited to, e.g., electrical information or a derivation thereof (e.g.,electrical potential information, such as intra-cardiac electrograminformation; electrical impedance information, such as fluidic ornon-fluidic cardiac tissue impedance information; electricalconductivity information, such as fluidic or non-fluidic cardiac tissueelectrical conductivity), thermal information or a derivation thereof(e.g., temperature information), fluid property information or aderivation thereof (e.g., blood flow information, blood pressureinformation), force information or a derivation thereof (e.g., contactinformation), and mapping information or a derivation thereof (e.g.,electrical mapping; physical feature mapping, such as anatomical featuremapping). In various embodiments, intra-cardiac information may berelated to any physiological parameter information related to a heartchamber. In various embodiments, intra-cardiac information may includeany information related to, or resulting from an interaction withintra-cardiac tissue. By way of non-limiting example, interaction withintra-cardiac tissue may include an interaction made by way of adiagnostic procedure or treatment procedure.

Intra-cardiac information may be acquired or received by various methodsand from various device systems. For example, FIG. 6B shows an explodedview of block 602, according to some embodiments. In particular, FIG. 6Bincludes a sub-block 602-a associated with computer-executableinstructions that receive or acquire the intra-cardiac information viadata sampling performed by a transducer-based device system (e.g., whichmay be at least part of the data input-output device system 120, 320)deployed externally from an intra-cardiac chamber or cavity (e.g.,outside the chamber or cavity or outside a body comprising the chamberor cavity). In this regard, the method 600 may include a sub-block 602-bin which the intra-cardiac information is generated (e.g., viageneration instructions executable by a data-processing device system,e.g., 110, 310) from data provided or sampled (e.g., according to thecomputer-executable sampling instructions associated with block 602-a)by the transducer-based device system deployed externally from theintra-cardiac chamber or cavity. Such generation according to block602-b, in some embodiments, may involve the associated instructionsconfiguring the data processing device system (e.g., 110, 310) torecognize and identify (e.g., in memory device system 130, 330) theincoming sampled data or a derivation thereof as a set of respectiveintra-cardiac information (e.g., as an electrocardiogram or other formof intra-cardiac information discussed herein). By way of non-limitingexample, various transducer-based device systems employed as per block602-a may include various fluoroscopy device systems, ultra-sound devicesystem, magnetic resonance device systems, computerized tomographydevice systems, and transthoracic electrocardiographic mapping devicesystems. It is noted that some of the embodiments associated with block602-a are considered to employ non-invasive methods or technologies.

FIG. 6C shows an exploded view of block 602, according to someembodiments. In particular, FIG. 6C includes a sub-block 602-cassociated with computer-executable instructions that are configured tocause reception or acquisition of the intra-cardiac information via datasampling performed by a transducer-based device system (e.g., which maybe at least part of the data input-output device system 120, 320)deployed internally to an intra-cardiac chamber or cavity. In thisregard, the method 600 may include a sub-block 602-d in which theintra-cardiac information is generated (e.g., via generationinstructions executed by a data-processing device system (e.g., 110,310) from data provided or sampled (e.g., by the sampling instructionsassociated with block 602-c) by the transducer-based device systemdeployed internally within the intra-cardiac chamber or cavity (e.g.,inside the chamber or cavity). Such generation according to block 602-d,in some embodiments, may involve the associated instructions configuringthe data processing device system (e.g., 110, 310) to recognize andidentify (e.g., in memory device system 130, 330) the incoming sampleddata or a derivation thereof as a set of respective intra-cardiacinformation (e.g., as an intra-cardiac electrogram or other form ofintra-cardiac information discussed herein). By way of non-limitingexample, various transducer-based device systems that may be internallydeployed within an intra-cardiac chamber include by way of non-limitingexample transducer-device systems 200, 300. Various transducer-baseddevice systems employed as per block 602-c may include variousintravascularly deployable or percutaneously deployable catheter devicesystems. Various transducer-based device systems employed as per block602-c may include detection capabilities, mapping capabilities,diagnostic capabilities, treatment capabilities or any combinationthereof. It is noted that some of the embodiments associated with block602-c may be considered to employ invasive methods or technologies.

Referring back to FIG. 6A, the displaying of the graphicalrepresentation according to the computer-executable instructionsassociated with block 604 may, in some embodiments, include causingdisplaying of a graphical representation of intra-cardiac informationgenerated, acquired, or received according to the computer-executableinstructions associated with block 602. Various embodiments may processor analyze (e.g., according to the instructions associated with block604) the transducer data received by the data processing device systemaccording to the computer-executable instructions associated with block602 in order to, for example, generate and cause the displayed graphicalrepresentation 500 to include the intra-cardiac information. Variousembodiments may process or analyze the transducer data received by thedata processing device system according to the instructions associatedwith block 602 in order to, for example, generate and possibly cause thedisplayed graphical representation 500 to include a map of theintra-cardiac information. In various embodiments, the data is sampledby a transducer-based device system from a plurality of locations in acardiac chamber and the generation instructions associated with block602 cause mapping of each of a plurality of parts of the intra-cardiacinformation to a respective one of the plurality of locations in thecardiac chamber. In some of these various embodiments, the displayinstructions associated with block 604 are configured to cause aninput-output device system (e.g., 120, 320) to display the plurality ofparts of the intra-cardiac information with a first spatial relationshipthat is consistent with a second spatial relationship between theplurality of locations in the cardiac chamber (e.g., a map of the partsof the intra-cardiac information is displayed). In some embodiments, thetransducer-based device includes a plurality of transducers (e.g.,transducer-based device 200, 300) and the sampling instructions (e.g.,602-c) are configured to cause the sampled data to be sampledconcurrently from the plurality of locations in the cardiac chamber.

It should be noted that some embodiments need not be limited to anyparticular form of processing or analysis of the transducer datareceived by the data processing device system according to theinstructions associated with block 602. Although various displayprocedures can be implemented according to the computer-executableinstructions associated with block 604 to display intra-cardiacinformation, these display procedures can be performed at other times,such as any time during the generation of or after the display of agraphical representation of at least a portion of a transducer-baseddevice (e.g., as per the computer-executable instructions associatedwith block 606).

An example of a display of a graphical representation that at leastdepicts intra-cardiac information according to various embodiments (suchas those represented by block 604 in FIG. 6A) would be a mappinglocating the position of the ports of various bodily openings positionedin fluid communication with a cardiac chamber. For example, in someembodiments, it may be desired to determine intra-cardiac informationindicating the locations of various ones of the pulmonary veins or themitral valve that each interrupts an interior surface of anintra-cardiac cavity such as a left atrium.

In some example embodiments, the mapping is based at least on locatingsuch bodily openings by differentiating between fluid and tissue (e.g.,tissue defining a surface of a bodily cavity). There are many ways todifferentiate tissue from a fluid such as blood or to differentiatetissue from a bodily opening in case a fluid is not present. Fourapproaches may include by way of non-limiting example:

1. The use of convective cooling of heated transducer elements by fluid.A slightly heated arrangement of transducers that is positioned adjacentto the tissue that forms the interior surface(s) of a bodily cavity andacross the ports of the bodily cavity will be cooler at the areas whichare spanning the ports carrying the flow of fluid.

2. The use of tissue impedance measurements. A set of transducerspositioned adjacently to tissue that forms the interior surface(s) of abodily cavity and across the ports of the bodily cavity can beresponsive to electrical tissue impedance. Typically, heart tissue willhave higher associated tissue impedance values than the impedance valuesassociated with blood.

3. The use of the differing change in dielectric constant as a functionof frequency between blood and tissue. A set of transducers positionedaround the tissue that forms the interior surface(s) of the atrium andacross the ports of the atrium monitors the ratio of the dielectricconstant from 1 KHz to 100 KHz. Such can be used to determine which ofthose transducers are not proximate to tissue, which is indicative ofthe locations of the ports.

4. The use of transducers that sense force (e.g., force sensors). A setof force detection transducers positioned around the tissue that formsthe interior surface of the bodily cavity and across the bodily openingsor ports of the bodily cavity can be used to determine which of thetransducers are not engaged with the tissue, which is indicative of thelocations of the ports.

The graphical interface of FIG. 5G includes various regions 525 a, 525b, and 525 c (e.g., part of a plurality if regions collectively referredto as regions 525) added to the graphical representation 500 shown inFIG. 5E. The regions 525 could be displayed according to theinstructions associated with block 604 in FIG. 6A in some embodiments.Although, such regions 525 could be displayed at other times oraccording to other instructions. In some embodiments, the graphicalinterface depicted in FIG. 5G is generated after the transducer-baseddevice is received in a bodily cavity having various anatomical featuresof interest and the drop-down selection box 526 identified as “ SurfaceMap” is activated via the input-output device system to select a modereferred to as “Flow”. Techniques for flow-based mapping techniques aredisclosed in commonly assigned U.S. Patent Application Publication No.:US 2008/0004534. In various embodiments associated with various ones ofFIG. 5, the anatomical features of interest are ports of a mitral valveand various pulmonary veins positioned in fluid communication with anintra-cardiac cavity (e.g., a left atrium in some embodiments). In thesevarious embodiments, the transducers of the transducer-based device aredistributed adjacent respective regions in the intra-cardiac cavity thatcan include relatively lower blood flow regions (e.g., adjacent a tissuesurface of the intra-cardiac cavity) and relatively higher flow regions(e.g., over the ports of the intra-cardiac cavity). It is noted thatrelatively lower blood flow regions in the intra-cardiac cavity mayoccur when a transducer is positioned in contact with a tissue surfaceto restrict blood flow at the contacted tissue. In some exampleembodiments, a relatively large number of transducers in thedistribution advantageously allow for each of the transducers to bepositioned adjacent their corresponding regions with little or norepositioning of the transducer-based device thereby facilitating anobtaining of transducer-based data concurrently from multiple locationsin the bodily cavity.

One or more of the above-discussed mapping procedures may be implementedaccording to instructions associated with block 604 to display agraphical representation 500 that includes intra-cardiac informationthat indicates at least a portion of one or more anatomical featuresbased at least on an analysis of the transducer data provided accordingto block 602. In some of these embodiments, the one or more anatomicalfeatures are the ports of various bodily openings (e.g., pulmonaryveins, left atrial appendage, mitral valve) positioned in fluidcommunication with the intra-cardiac cavity and the transducer dataincludes data containing various blood flow data within the bodilycavity. In various embodiments, the data sampled according to block 602is temperature data and the graphical representation 500 includes agraphical representation of at least some of the temperature data or aderivation thereof. For example, in various embodiments in which the useof convective cooling of heated transducer elements by fluid is employedto distinguish blood flow adjacent to the tissue that forms the interiorsurface(s) of a cardiac chamber from blood flow across the ports of thecardiac chamber, temperature data associated with the convective coolingcan be sampled and displayed to provide the graphical representation ofthe intra-cardiac information. In FIG. 5G, the relatively large region525 a (e.g., shown as two parts in this particular orientation of thetwo-dimensional representation) is associated with the mitral valve,region 525 b is associated with the left atrial appendage, and regions525 c are associated with various pulmonary vein groups. Each of theregions 525 is depicted in the graphical representation 500 with agraduated pattern provided by the flow identifier 527 a in the graphicalinterface of FIG. 5G. In some embodiments, flow identifier 527 aprovides a graduated scale from a condition indicated as “Contact”(e.g., when a transducer is contact with cardiac tissue) to a conditionindicated as “Flow” (e.g., when a transducer overlies a port in thecardiac chamber). A graduated pattern can be employed to indicatevarious regions in the graphical representation corresponding todifferent regions of flow in the intra-cardiac cavity. The identifiedregions 525 may be identified by any suitable methods including the useof gray-scale patterns, different colors, different opacities, differentintensities and different shapes. It is understood that otherembodiments may employ other techniques to identify regions in thegraphical representation corresponding to a desired anatomical feature.For example, transducer-based data containing blood and tissue impedanceinformation may be employed to determine regions 525 as shown in FIG.5H. In various embodiments, drop-down selection box 526 may be operatedto allow for the selective inclusion in the graphical representation ofimpedance data (e.g., tissue impedance data) or conductivity data (e.g.,tissue conductivity data). In FIG. 5H, the relatively large region 525-1a (e.g., shown as two parts in this particular orientation of thetwo-dimensional representation) is associated with the mitral valve,region 525-1 b is associated with the left atrial appendage, regions525-1 c are associated with various pulmonary vein groups. Each of theregions 525 is depicted in the graphical representation 500 with agraduated pattern provided by the impedance identifier 527 b in thegraphical interface of FIG. 5H. In some embodiments, impedanceidentifier provides a graduated scale from a condition indicated as“Low” (e.g., when a transducer overlying a port in the cardiac chamberis used to measure the electrical impedance of blood) to a conditionindicated as “High” (e.g., when a transducer adjacent cardiac tissue isused to measure the electrical impedance of cardiac tissue). A graduatedpattern can be employed to indicate various regions in the graphicalrepresentation corresponding to different regions of impedance in theintra-cardiac cavity. The identified regions 525 may be identified byany suitable methods including the use of gray-scale patterns, differentcolors, different opacities, different intensities, and differentshapes. It is understood that other embodiments may employ othertechniques to identify regions in the graphical representationcorresponding to a desired anatomical feature.

Identification of the regions 525 may be motivated for various reasons.For example, in embodiments in which transducers of transducer-baseddevice are activated to treat, diagnose, or investigate various regionsin a bodily cavity, the identification of various regions 525 and theirspatial relationship relative to one another may impact the efficacy ofthe treatment, diagnostic, or investigative procedure. For example, insituations in which at least some of the transducers of atransducer-based device are employed to ablate various regions within anintra-cardiac cavity (e.g., to treat atrial fibrillation), ablation of apulmonary vein may result in an undesired condition referred to aspulmonary stenosis. Identification of various ones of the regions 525 c(e.g., 525-1 c) in the graphical representation along with their spatialrelationship with various ones of the transducers at various times maybe employed to reduce occurrences of this undesired condition.

Without limitation, other forms of intra-cardiac data (e.g., asreceived, acquired, provided, generated, or sampled per block 602) thatmay form part of the graphical representation 500 may include pressuredata (e.g., blood pressure data, contact pressure data),electrophysiological activation timing data, isochronal data,propagation data, electrophysiological isopotential data, and otherelectrophysiological voltage data. Without limitation, various maps ofintra-cardiac data may include tissue contact maps (e.g., contact mapsinferred from flow data, impedance data, conductivity data), activationmaps indicating the local activation times associated with a particularcardiac event, isochronal maps where contour lines may delineate regionsof equal activation times associated with a particular cardiac event,propagation maps providing a dynamic representation of the movingactivation wave-front associated with a particular cardiac event,isopotential maps, and various other voltage maps associated withintra-cardiac electrical activity. Various representations (e.g., maps)of intra-cardiac information may include portions corresponding tovalues measured at specific locations within an intra-cardiac cavity andportions corresponding to values that are interpolated (for example,interpolated from values measured at specific locations within anintra-cardiac cavity).

In some embodiments, intra-cardiac information is depicted in thegraphical representation statically or relatively statically. That is,the displayed intra-cardiac data remains unaltered or relativelyunaltered during a defined display period. In some embodiments,intra-cardiac information is depicted in the graphical representation500 such that variances in the intra-cardiac information are shownoccurring over a defined display period. In some embodiments, thegraphical representation includes an animation of changes inintra-cardiac information. FIGS. 5I, 5J, and 5K show graphicalrepresentation 500 including changes in intra-cardiac informationoccurring at three successive particular times during a display period.In some embodiments, the intra-cardiac information displayed in each ofFIGS. 5I, 5J, and 5K includes intra-cardiac voltage data showing adistribution of voltage values of intra-cardiac electrogram data sampled(e.g., using a transducer-based device system 200, 300) at a particulartime (i.e., each of the FIGS. 5I, 5J, and 5K associated with arespective different particular time), each of the voltage valuesassociated with intra-cardiac electrogram data or information sampled atthe particular time at a respective one of a plurality of locations inan intra-cardiac cavity (e.g., by respective transducers).

In some embodiments, the displayed voltage values include positivevalues, negative values, or both positive and negative values. Forexample, various positive and negative voltage values are indicated inthe graphical representation 500 shown in each of FIGS. 5I, 5J, and 5K,a magnitude and positive or negative indication varying in accordancewith the voltage identifier 527 c. The voltage values shown in FIGS. 5I,5J, and 5K may be identified by any suitable methods including the useof gray-scale patterns, different colors, different opacities, differentintensities, and different shapes. In some embodiments, a grey-scale orcolor-scale pattern extending across both a positive and negative rangeis employed to represent the various voltage values or ranges of voltagevalues. In various embodiments, at least some of the displayed voltagevalues may include a peak value corresponding to a peak amplitudeportion of a waveform representative of the intra-cardiac electrogramdata or information associated with the particular displayed voltagevalues. In various embodiments, at least some of the displayed voltagevalues may include a non-peak value corresponding to non-peak amplitudeportion of a waveform representative of the intra-cardiac electrogramdata or information associated with the particular displayed voltagevalues. Without limitation, various ones of the displayed voltage valuesmay include derivations of the actual measured voltage values (e.g.,values derived from the actual measured voltage values) including RMSvalues, peak-to-peak values.

In various embodiments, the sequence depicted in FIGS. 5I, 5J, and 5Kshows time-varying changes in the voltage values associated with theintra-cardiac voltage data or information sampled at respective ones ofa plurality of locations in an intra-cardiac cavity. By concurrentlysensing intra-cardiac voltage data at each of plurality of locationswithin an intra-cardiac cavity at various successive times, arelationship indicating changes among all the voltage values associatedthe intra-cardiac voltage data or information sampled at varioussuccessive times across all of a plurality of locations in anintra-cardiac cavity is shown. For example, FIGS. 5I, 5J, and 5K includea depiction of various voltage values represented by moving wave-front529 (sometimes referred to as propagation 529). In this case, the movingwave-front 529 of voltage values propagates generally in a directionindicated by arrow 529 a (not part of the graphical representation 500but provided to clarify the direction of propagation of wave-front 529shown in the sequence depicted in FIGS. 5I, 5J, and 5K). It isunderstood that the propagation of the wave-front 529 of voltage valuesis not limited to the direction indicated by arrow 529 a, but rather, isinfluenced by various physiological factors associated with the flow ofvarious electrical signals within the cardiac tissue.

In some embodiments, the appearance of a propagating wave-front 529 a iscaused by changes in the voltage values at each of a plurality oflocations in the graphical representation 500, the changes at eachparticular location represented by changes in a visual characteristic ofthe voltage value at that particular location. In this regard, anessentially real-time or quasi-real-time representation of thepropagation of various electrical signals within an intra-cardiac cavitymay be depicted.

It is noted that in various example embodiments such as those associatedwith various ones of FIGS. 5G, 5H, 5I, 5J, and 5K, at least some of thegraphical elements 501 (e.g., transducer graphical elements 502, betweengraphical elements 504) are depicted as overlaid or superimposed on thedisplayed graphical representation 500 that includes a depiction of theacquired intra-cardiac information. In various embodiments, various onesof the graphical elements 501 (e.g., various ones of the transducergraphical elements 502) are depicted with a transparent,semi-transparent, or translucent appearance that allows a user to viewregions of the intra-cardiac information that underlie each of thevarious ones of the graphical elements 501 or visual changes in theregions of the intra-cardiac information that underlie each of thevarious ones of the graphical elements 501. This configuration can beespecially advantageous when one hundred, two hundred, or even moretransducers are employed percutaneously to sample or gather theintra-cardiac information from a cardiac chamber. A graphicalrepresentation 500 that employs a similar, equal, or greater number ofgraphical elements 501 (e.g., transducer graphical elements 502, betweengraphical elements 504 or both transducer graphical elements 502 andbetween graphical elements 504) may obstruct a required viewing of thedisplayed intra-cardiac information, especially when transducergraphical elements 502 having a shape consistent with the shapes ofcorresponding ones of the transducers are employed or when transducergraphical elements having distorted appearances (e.g., enlargeddistorted appearances described above) are employed. These situationsmay be effectively mitigated by the use of various graphical elements501 having a transparent, semi-transparent, or translucent appearance.

Having described examples of the graphical representation displayedaccording to the instructions associated with block 604 in FIG. 6A, thedefinition of a graphical path (e.g., via input-output device system,120, 320) according to some embodiments will be described with respectto block 610 in FIG. 6A. In various embodiments, the defined graphicalpath is depicted in the graphical representation 500, for example, among(a) the graphical elements 501, (b) the representation of theintra-cardiac information, or both (a) and (b). In various embodiments,the graphical path may be defined, at least in part, based on (a) apositional relationship between various ones of the graphical elements501, (b) a positional relationship between various regions of therepresentation of the intra-cardiac information, (c) a positionalrelationship between various ones of the graphical elements 501 andvarious regions of the representation of the intra-cardiac information,or a combination of two or more of (a), (b) and (c).

The graphical path defined in accordance with the computer-executableinstructions associated with block 610 may take various forms, shapes,or configurations including embodiments that include, by way ofnon-limiting example, an elongated portion, a continuous portion, aninterrupted portion, a linear portion, an arcuate portion, a portiondefining an obtuse angle, a portion defining an acute angle, a beginningportion (e.g., a portion defining or associated with a beginning orstart of the definition of the graphical path), an end portion (e.g., aportion defining or associated with an end or termination of thedefinition of the graphical path), an open or closed circumferentialportion, or any combination thereof. In various embodiments, a graphicalpath defined in accordance with the instructions associated with block610 may include a plurality of graphical-path-elements. In variousembodiments, a graphical path defined in accordance with theinstructions associated with block 610 may include selection of some butnot all of a plurality of selectable graphical-path-elements.

The definition of the graphical path in accordance with the instructionsassociated with block 610 may be accomplished at least in part byexecution of various instructions by the data processing device system(e.g., exemplified by data processing device systems 110 or 310)responsive to various user instructions, inputs or actions. Forinstance, in some embodiments, a user instruction, input, or action mayoriginate from a user selecting a particular region or regions ofgraphical representation 500. In this case, various instructions mayconfigure the data processing device system to recognize this userinstruction when it is received via an input-output device system (e.g.,110, 310) as a user instruction to form or define at least a portion ofthe graphical path. For example, user selection of a region 525 c inFIGS. 5L and 5M may cause the data processing device system (configuredaccording to the instructions associated with block 610) to define agraphical path 505 including transducer graphical elements 502 andbetween graphical elements 504 (shown, e.g., in solid-colored interiordarkening) around such region 525 c (e.g., by identifying transducerswhere the absolute value of the data, which causes region 525 c,decreases to match the lighter colored regions in representation 500).

Definition of the graphical path may be motivated for different reasons.For example, in some embodiments, an activation (e.g., according tocomputer-executable instructions associated with block 614) of varioustransducer sets of a transducer-based device (e.g., 200, 300, or 400),initiated during or after the completion of the definition of thegraphical path according to the instructions associated with block 610,may cause energy sufficient for tissue ablation along an ablation pathcorresponding to the defined graphical path. Advantageously in someembodiments, the ability to define a graphical path based at least on agraphical representation that includes at least a representation ofintra-cardiac information may allow for enhanced results, or a possiblereduction in undesired results during a subsequent ablation of cardiactissue within an intra-cardiac cavity (e.g., an intra-cardiac cavitythat is the source of the intra-cardiac information) when the graphicalpath acts as a template for a desired ablation path. In this regard, adesired ablation path may be defined based at least on a modeledgraphical path that may be generated based at least on various possibleconstraints indicated by the graphical representation of theintra-cardiac information. For example, various representations ofintra-cardiac information that indicate at least a portion of one ormore anatomical features (e.g., various cardiac ports provided by thepulmonary veins, left atrial appendage, mitral valve as shown in FIGS.5G and 5H by way of non-limiting example) may be used to assist a userin defining a graphical path that acts as a basis for a subsequentablation path that takes into consideration (e.g., avoids) theseanatomical features and reduce occurrences of undesired complications(e.g., stenosis which may arise if ablative energy is applied toparticular ones of these anatomical features).

In various embodiments, the graphical representation 500 includes arepresentation of various transducers of a transducer-based device(e.g., 200, 300 or 400) positioned within the intra-cardiac cavity. Forexample, a mapping indicating a particular positioning, pose, ororientation of the transducer-based device in the intra-cardiac cavity,and in particular, a spatial positioning between various ones of thetransducers and various regions of the depicted intra-cardiacinformation may be displayed. It is noted that in various embodiments,the intra-cardiac information that is displayed (e.g., via theinstructions associated with block 604) need not be static and mayinclude changes in the displayed appearance thereof, for example duringthe generation of the graphical path or thereafter. In some embodiments,the graphical representation 500 may form a basis for the definition ofa particular graphical path that identifies particular ones of thetransducers that may be suitable to ablate along an ablation pathcorresponding to the defined graphical path. Other motivations may drivethe definition of the graphical path in other embodiments.

Block 612 in FIG. 6A may be associated with instructions configured tocause display of the graphical path (e.g., 505) defined according to theinstructions associated with block 610. Such instructions may configurea data processing device system (e.g., 110, 310) to change a visualcharacteristic (e.g., changing a color or overlaying a graphical objecton top) of at least part of each of at least some of the selectedgraphical elements in the graphical path (e.g., 505). For example,various ones of the particular illustrated embodiments shown in FIGS.5L, 5M show a plurality of portions of a graphical path 505 displayedaccording to the instructions associated with block 612 as graphicalelements 501 with solid-colored interior darkening, each selectedportion of the graphical path 505 indicating a selection of at least oneof the graphical elements 501. FIG. 5L shows at least a two-dimensionalrepresentation of the graphical path 505, while FIG. 5M shows at least athree-dimensional representation of the graphical path 505, according tovarious embodiments. In some embodiments, the graphical path displayedaccording to the instructions associated with block 612 is displayedamong a graphical representation of intra-cardiac information. Suchintra-cardiac information may include “flow-based” intra-cardiacinformation similar to or the same as that shown in FIG. 5G, as shown ineach of FIGS. 5L and 5M, but it is understood that other forms ofintra-cardiac information may be displayed in other embodiments. In someembodiments, various combinations of the display instructions associatedwith block 604, the display instructions associated with block 606, andthe display instructions associated with block 612 are provided by asame set of display instructions.

In the particular illustrated embodiments shown in FIGS. 5L and 5M,additional information 521 is displayed upon a selection indicating aparticular one of the graphical elements 501. In these particularembodiments, the information 521 includes target temperature informationassociated with each of the transducers corresponding to the particularones of the directly or indirectly selected transducer graphicalelements 502. In some embodiments, the information 521 is related to, orreflective of systems-based or hardware-based information. In someembodiments, the information 521 is related to, or reflective ofphysiological parameter information. In some embodiments, targettemperature information may be employed to monitor or control thetransmittance of tissue ablation energy from a particular one of thetransducers. In various embodiments temperature data is sensed by aparticular temperature sensor (e.g., temperature sensor 408) provided bya particular transducer. The temperature data may, in some embodiments,be compared with the target temperature to monitor or control thetransmittance of tissue ablation energy from the particular transducers.Other forms of information 521 may be displayed in other embodiments. Itis noted that in some embodiments, the display of information 521 occursin response to a selection of various ones of the graphical elements501. Advantageously, the selective inclusion of information 521 only forthe selected ones of the graphical elements 501 may reduce a clutteringthe display region if the information 521 were provided for asignificant number of (e.g., a majority) or all of the selectablegraphical elements 501. This limited display of additional information521 may be especially important when several hundreds of selectablegraphical elements 501 are displayed.

In various embodiments, a plurality of graphical representations ofelectrograms 535 are additionally displayed (e.g., by the displayinstructions associated with block 604) by the graphical interface, eachof the electrograms 535 derived from data sampled by a respectivetransducer (e.g., transducer 306, 406) corresponding to particular oneof the transducer graphical elements 502 selected along the graphicalpath (e.g., 505). For example, the electrograms 535 in FIGS. 5L and 5Mmay be generated or derived according to the computer-executableinstructions associated with block 602-d from intra-cardiac voltage datasampled in accordance with the computer-executable instructionsassociated with block 602-c. In various embodiments, each of theelectrograms 535 is a unipolar or monopolar electrogram.

Returning to FIG. 6A, block 608 includes instructions configured tocause a reception of a selection of a graphical element, according tosome embodiments. In some embodiments, the computer-executableinstructions associated with block 608 are provided in a program thatincludes instructions configured to cause the data processing devicesystem (e.g., 110, 310) to receive a selection from the input-outputdevice system of a transducer graphical element (e.g., transducergraphical element 502), for example, to generate at least in part agraphical path (e.g., as per the instructions associated with block 610)similar to or the same as the graphical path 505 shown in FIGS. 5M and5L. In this regard, although blocks 608 and 610 are shown separately inFIG. 6A, block 608 may be part of block 610, according to someembodiments. In some embodiments, the selection according to block 608may occur by a user mouse-click or other user interface selectionoccurring at the display location of the graphical element or may occurby a user inputting (e.g., via a keyboard) an identifier (e.g., 513)associated with the selected graphical element. However, the inventionis not limited to any particular manner of selecting a graphicalelement.

The selection of one or more graphical elements according to theinstructions associated with block 608 in FIG. 6A may cause, in someembodiments, an activation of at least some transducer sets of atransducer-based device (e.g., 200, 300, or 400) according toinstructions associated with block 614. In some embodiments, block 614includes instructions configured to cause an activation of each of atleast some of the transducer sets of the transducer-based device (e.g.,again exemplified by transducer based devices 200, 300, or 400) inresponse to receiving a selection of a corresponding one of thegraphical elements (e.g., graphical elements 501) in accordance withselection instructions included in block 608.

In some embodiments, the program may include activation instructions(e.g., in accordance with block 614) configured to, in response toreceiving the selection (e.g., in accordance with block 608) of atransducer graphical element (e.g., transducer graphical element 502),cause, via the input-output device system, activation of the respectivetransducer of the transducer-based device corresponding to the selectedtransducer graphical element. In various embodiments, the instructionsconfigured to activate the respective transducer corresponding to theselected transducer graphical element include instructions that areconfigured to cause energy from an energy source device system (e.g.,energy source device system 340) to be delivered to the respectivetransducer, the energy sufficient for tissue ablation in some of thesevarious embodiments. In some embodiments, a sensing device system (e.g.,provided at least in part by a number of the transducers) is arranged tosense intra-cardiac information or physiological parameter informationat a respective location at least proximate the respective transducercorresponding to the selected transducer graphical element with theenergy delivered to the transducer. In some of these variousembodiments, an indifferent electrode (e.g., indifferent electrode 326)is provided (e.g., usually to an external surface or skin-based surfaceof a body) while the transducer-based device is received in a bodilycavity within the body. A portion of the tissue-ablating energydelivered to the respective transducer corresponding to the selectedtransducer graphical element may be transmitted from the respectivetransducer to the indifferent electrode in a process typically referredto as monopolar ablation. Other forms of activation of the respectivetransducer corresponding to the selected transducer graphical elementare possible in other embodiments. In some embodiments, activation ofthe respective transducer corresponding to the selected transducergraphical element under the influence of the instructions configured toactivate the respective transducer is referred to as monopolaractivation. Monopolar activation can include activation for monopolarablation or monopolar electrogram generation by way of non-limitingexample.

For another example, in some embodiments, the instructions associatedwith block 608 are provided in a program that includes selectioninstructions configured to cause, due to execution of the selectioninstructions by the data processing device system (e.g., againexemplified by data processing device systems 110 or 310), reception ofa selection from the input-output device system of a between graphicalelement (e.g., between graphical elements 504). In accordance with theinstructions associated with block 614 the program may includeactivation instructions configured to, in response to receiving theselection, cause activation, via the input-output device system, of arespective set of two or more of the transducers (e.g., a pair of thetransducers in some embodiments) of the transducer-based devicecorresponding to the between graphical element.

Advantageously, activating a set of two or more of the transducers basedon a selection of a single graphical element (e.g., between graphicalelement 504) provides for a workflow that is less cumbersome and moreexpeditious than individually selecting the respective graphicalelements (e.g., transducer graphical elements 502) associated with eachtransducer of the set of two or more of the transducers, especially when50, 100, 200 or even over 300 or more transducer graphical elements areprovided in the graphical representation. This is even moreadvantageous, when a single graphical element (e.g., between graphicalelement 504) provides additional information (e.g., spatial information)relating each of the transducers in the set of two or more of thetransducers. For example, a between graphical element 504 can indicate adistance between or acceptability-of-activation of transducers of acorresponding transducer pair, and, accordingly, the between graphicalelement 504 provides, in some embodiments, information about thecorresponding group (e.g., pair) of transducers and, thereby, makes theselection process more efficient. In addition, allowing selection of thebetween graphical elements for corresponding transducer activation canprovide a more intuitive user-interface in certain applications. Forexample, such an arrangement allows a user to make selections along anablation path or a path along which data is to be obtained, withouthaving to focus on the transducers required to make that ablation pathor acquire that data. The user can, for example, just select a pathusing between graphical elements (e.g., user-basedselection(s)/constituent selection(s)), and the correspondingtransducers are automatically selected (e.g., machine-basedselection(s)/constituent selection(s)) in response. Since various onesof the between graphical elements need not be tied to any physicalportion of the transducer-based device, they can be freely designed toreflect the path (e.g., over tissue or fluid) in which theircorresponding transducers will interact when activated (e.g., by causingablation or gathering data). In this regard, if the between graphicalelements are configured to accurately represent their respective pathsegments in which ablation or data gathering will occur, according tosome embodiments, the user can gain an even better understanding of theexpected results of activation of the corresponding transducers. Thisadvantageously increases the likelihood that an ablation path that isconsistent with a displayed graphical path will result in variousembodiments.

In various embodiments where the instructions according to block 614 areconfigured to cause a data processing device system to activate arespective set or group of two or more of the transducers, theinstructions according to block 614 include instructions that areconfigured to cause energy from an energy source device system (e.g.,energy source device system 340) to be delivered to the respective setof two or more of the transducers, the energy sufficient for tissueablation in some of these various embodiments. In some embodiments, asensing device system (e.g., sensing device system 325) is arranged tosense at least one tissue electrical characteristic (e.g., an example ofintra-cardiac information) at respective locations at least proximateeach transducer of the respective set or group of two or more of thetransducers with the energy delivered to the respective set of two ormore of the transducers. In some example embodiments, a selected betweengraphical element (e.g., between graphical element 504) isrepresentative of a physical path extending between a respective pair ofthe transducers associated with the selected between graphical elementand the energy is sufficient for ablating a portion of tissue extendingalong the physical path. A portion of the tissue-ablating energy may betransmitted between the respective pair of the transducers in a processtypically referred to as bipolar ablation. In some embodiments, anindifferent electrode (e.g., indifferent electrode 326) is provided(e.g., usually to an external surface or skin-based surface of a body)while the transducer-based device is received in a bodily cavity withinthe body. Some of the tissue-ablating energy may be transmitted betweenthe respective pair of the transducers while some of the tissue-ablatingenergy may be transmitted from various ones of the respective pair ofthe transducers to the indifferent electrode in a process typicallyreferred to as blended monopolar-bipolar ablation. The term “bipolarablation” as used in this disclosure is to be interpreted broadly toinclude blended monopolar-bipolar ablation in some embodiments.

In addition to embodiments where the instructions according to block 614are configured to cause a data processing device system to cause bipolarablation, the instructions according to block 614, in some embodiments,are configured to cause a data processing device system to causemulti-transducer monopolar ablation with the respective set of two ormore of the transducers, e.g., dual monopolar ablation for twotransducers, or triple monopolar ablation for three transducers. In suchcases, for example, the respective set of two or more of the transducersmay be ‘queued’ for monopolar ablation, such that monopolar ablationoccurs for each transducer in the respective set of two or more of thetransducers within some period of time, but not necessarily at the sametime or even contiguously one right after another. In this regard,references herein to the occurrence of monopolar ablation for more thanone transducer may include this multi-transducer monopolar ablationaccording to some embodiments. In addition, any reference herein to theoccurrence of bipolar ablation may be replaced with the occurrence ofdual monopolar ablation (or other multi-transducer monopolar ablationwhen more than two transducers are involved), according to someembodiments. In some cases in which multi-monopolar ablation isemployed, energy transfer sufficient to cause tissue ablation is nottransferred between the particular transducers employed by themulti-monopolar ablation. Rather, in these cases energy sufficient fortissue ablation is transmitted between each of these particulartransducers and an indifferent electrode (e.g., indifferent electrode326). In various embodiments, the activation instructions associatedwith block 614 may be configured to cause transmission, initiated duringor after completion of the definition of the graphical path (e.g.,graphical path 505) of energy sufficient for tissue ablation from atleast each respective transducer corresponding to each transducergraphical element (e.g., 502) selected, indicated or passed through bythe graphical path defined in accordance with the computer-executableinstructions associated with block 610. In some embodiments, thecomputer-executable instructions associated with block 614 that are, insome embodiments, configured to activate the respective transducercorresponding to the selected transducer graphical element includeinstructions that are configured to cause a sensing device system (e.g.,sensing device system 325) to detect, sense or sampleelectrophysiological data including intra-cardiac voltage data (anexample of intra-cardiac information in some embodiments) at a locationin a bodily cavity or chamber at least proximate the respectivetransducer. The detected electrophysiological activity can be displayedas an intra-cardiac electrogram via the input-output device system (e.g.electrograms 535 shown in FIGS. 5L and 5M). In some embodiments,detection of electrophysiological activity in an intra-cardiac cavity ata location at least proximate various ones of the transducers occurscontinuously and is not necessarily dependent on a particular selectionof a graphical element 501.

In some embodiments, the detected, sensed, or sampled intra-cardiacinformation (e.g., sampled intra-cardiac voltage data) is employed toassess various levels of lesion (e.g., an ablated tissue region)transmurality achieved at various times during a tissue ablation process(e.g., a cardiac tissue ablation process). For example, FIG. 7A shows anexample intra-cardiac electrogram 535 a during a cardiac tissue ablationprocedure, which may be displayed, e.g., as part of the graphicalrepresentations of any of FIG. 5 (e.g., as at least part of one of thesubpanels displaying one or more graphical representations of at leastone of the intra-cardiac electrograms 535 shown in the panel ofintra-cardiac electrograms displayed by the graphical representation inFIGS. 5L and 5M). In FIG. 7A, the cardiac tissue ablation procedure isperformed by transmitting RF ablation energy via one particulartransducer electrode (e.g., a particular electrode 315, 415) during thegeneration of the intra-cardiac electrogram 535 a. In this particularcase, the cardiac tissue ablation procedure is performed by transmittingRF ablation energy (e.g., energy sufficient to cause tissue ablation)via one particular transducer electrode (e.g., a particular electrode315, 415) during the sampling of intra-cardiac voltage data from whichthe intra-cardiac electrogram 535 a is derived. In some embodiments, thedisplayed intra-cardiac electrogram 535 a data is provided from datasampled during a time period starting when or after the ablation of thecardiac tissue begins. Changes in the intra-cardiac electrogram datathroughout the time period are displayed as the cardiac tissue ablationprocedure proceeds. In some embodiments, the same electrode that isemployed to perform the cardiac tissue ablation is employed to samplethe intra-cardiac voltage data. In other cases, a transducer other thana transducer employed to perform the tissue ablation may be employed tosample the intra-cardiac voltage data (e.g., the sampling or sensingtransducer electrode is distinct from the ablation transducer orelectrode). In some embodiments, a same electrode is employed toconcurrently sample and ablate the cardiac tissue (e.g., the sampling orsensing transducer electrode is the ablation transducer or electrode).It is noted, however, that intra-cardiac data may be sampled by atransducer other than an ablation transducer in other cases (forexample, a sampling by an intra-cardiac voltage sampling transducer at alocation at least proximate a tissue ablated by an ablation transducer).In some embodiments, intra-cardiac voltage data is sampled by anelectrode while the electrode is positioned at a same location in anintra-cardiac cavity throughout a tissue ablation period that canencompass a plurality of cardiac cycles. An electrocardiogram (ECG/EKG)523 a may also be additionally provided (e.g., by the graphicalinterface shown in various ones of FIG. 5) to further interrelatevarious portions of the intra-cardiac electrogram 535 a to variouscardiac cycles or portions thereof as described below.Electrocardiograms provide an interpretation of the electrical activityof the heart over a time period. Electrocardiograms are detected byelectrodes attached to an external or skin-based surface of the body andare recorded or displayed by a device external to the body. In thisregard, electrocardiograms are generated transthoracically (i.e., acrossthe thorax or chest).

Unlike electrograms provided by various conventional systems,electrogram 535 a has a particularly well established form withrelatively low noise that is typically characteristic of theelectrograms provided by the various transducer-based device systemsdisclosed herein due at least to the structure of the transducersdescribed according to FIG. 4, above. In this particular case,electrogram 535 a includes a biphasic portion 536 a (e.g., anelectrogram portion that contains both positive and negative voltagepeaks) during the early phases of the cardiac ablation procedure. It isnoted that that electrogram 535 a is typically biphasic in nature priorto ablation. The present inventors have noted, however, that thebiphasic portion 536 a is typically transient in nature during theactual ablation and transitions into monophasic portion 536 b (e.g., anelectrogram portion that contains or primarily contains either onlypositive voltage peaks or only negative voltage peaks or contains onlypositive voltage peaks that are much greater than the absolute value ofthe negative voltage peaks (e.g., at least two, three, or four timesgreater)). In this regard, it is noted that the transformation from thebiphasic portion 536 a to the monophasic portion 536 b occurs over aplurality of cardiac cycles (shown approximately by reference numeral536 c for the embodiments of FIG. 7A, but other durations oftransformations will occur depending upon at least ablative energydelivery characteristics and tissue characteristics). The presentinventors have further noted that the various monophasic peaks in themonophasic portion 536 b increase in amplitude and reach a maximum value(e.g., maximum peak 537-1), then reduce in amplitude, and eventuallyplateau as the ablation progresses, as described below in detail withrespect to FIG. 7.

For clarity, FIGS. 7B, 7C, and 7D are provided to show detailed portionsof intra-cardiac electrogram 535 a during different times during thecardiac tissue ablation procedure that spans a plurality of cardiaccycles. As employed herein, the phrase “cardiac cycle” refers to a timeperiod of a complete heartbeat from its generation to the beginning ofthe next beat, and includes the diastole, the systole, and anintervening pause. A frequency of the cardiac cycle is described by theheart rate, which is typically expressed as beats per minute. Diastolerepresents the period of time when the ventricles are relaxed (e.g., notcontracting). During diastole, blood is passively flowing from the leftatrium and right atrium into the left ventricle and right ventricle,respectively. The blood flows through the mitral and tricuspid valves(also known as the atrioventricular valves) separating the atria fromthe ventricles. The right atrium receives blood from the body throughthe superior vena cava and inferior vena cava. The left atrium receivesoxygenated blood from the lungs through four pulmonary veins that enterthe left atrium. At the end of diastole, both atria contract, propellingblood into the ventricles. Systole occurs when the left and rightventricles contract and eject blood into the aorta and pulmonary artery,respectively. During systole, the aortic and pulmonic valves open topermit ejection into the aorta and pulmonary artery. Theatrioventricular valves are closed during systole, therefore no blood isentering the ventricles; however, blood continues to enter the atriathough the vena cava and pulmonary veins. Throughout the cardiac cycle,blood pressure increases and decreases. The cardiac cycle is coordinatedby a series of electrical impulses that are produced by specializedheart cells found within the sinoatrial node and the atrioventricularnode.

Each of FIGS. 7B, 7C, and 7D include respective portions of theelectrocardiogram (ECG/EKG) 523 a of FIG. 7A occurring during therespective times associated with each of the respective figures. It isnoted that the various information (e.g., X axis and Y axis headers,scales) may not be present in the actual content displayed (e.g., via arespective subpanel in one or more of FIG. 5), but are included hereinfor the convenience of discussion. Typically, an electrocardiogram(e.g., 523, 523 a) has five deflections or peaks identified as the Pwave, Q wave, R wave, S wave, and T wave, the deflections or peakscollectively marking a cardiac cycle. It is noted that a U Wave (notidentified in FIGS. 7B, 7C and 7D) may follow the T wave in the cardiaccycle, but such U wave is typically of low amplitude and may not bevisible in various electrocardiograms. The Q, R, and S waves generallyoccur in rapid succession, and the combination of three of these wavesis typically referred to as the QRS complex. The QRS complex generallycorresponds to the depolarization of the right and left ventricles ofthe heart, and at least the R wave thereof is readily visible inelectrocardiograms. The P wave marks a deflection in theelectrocardiogram produced by excitation of the atria of the heart,while the T wave represents the repolarization (or recovery) of theventricles in the electrogram. Ventricular systole begins at the QRScomplex, and atrial systole begins at the P wave.

A V wave in the electrogram 535 a typically corresponds to theventricular depolarization corresponding to at least the R wave portionof the QRS complex in the electrocardiogram 523 a. The V wave istypically not as pronounced or prominent in intra-cardiac electrogramsas the R wave is in electrocardiograms. A magnitude of the V wave mayvary from electrogram to electrogram when each electrogram is derivedfrom respective data sampled from a respective different location withinan intra-cardiac cavity. It is understood that the indication of the Pwave, Q wave, R wave, S wave, T wave, and V wave in various ones of FIG.7 are provided for convenience of discussion and may not actually formpart of the display of the respective electrocardiogram or the displayof the respective intra-cardiac electrogram as the case may be.

FIG. 7B includes a display of at least part of the biphasic portion 536a of intra-cardiac electrogram 535 a (e.g., as displayed by thegraphical interface of FIG. 5). Little changes in the amplitude andother characteristics of the peaks of the biphasic pulses in portion 536a appear during this time in the ablation procedure. FIG. 7C includes atleast part of the monophasic portion 536 b of intra-cardiac electrogram535 a including peak 537-1. In this particular case, peak 537-1 has anamplitude of approximately 5 millivolts and occurs approximately 7.8seconds after the start of the tissue ablation, although the inventionis not limited to such amplitude and timing, which depend on manyfactors, such as tissue thickness, ablation energy,ablation-electrode-to-tissue-contact, etc. Peak 537-1 marks anoccurrence of a particular situation in which the intra-cardiacelectrogram 535 a (and, in particular, the monophasic portion 536 b)reaches a maximum voltage value or a maximum amplitude. Peak 537-1 marksan occurrence of a particular situation in which the amplitude of a peak537 of a portion of the intra-cardiac electrogram 535 a (and, inparticular, the monophasic portion 536 b) derived from data sampledduring a particular cardiac cycle during the ablation reaches an overallmaximum value or peak value as compared with the amplitudes of therespective peaks of other portions of the intra-cardiac electrogram 535a that are derived from data sampled during the other cardiac cyclesoccurring during the ablation. It is noted that, in some embodiments,intra-cardiac electrogram 535 a may be considered to be a monophasicintra-cardiac electrogram according to definitions set forth above withrespect to monophasic portion 536 b.

FIG. 7D includes at least part of the monophasic portion 536 b ofintra-cardiac electrogram 535 a in which an amplitude of various ones ofthe monophasic pulses has plateaued and reached a voltage value ofapproximately 1 millivolt which remains relatively constant (e.g.,+/−15% or +/−0.3 millivolts in some embodiments) during this time in thetissue ablation. The indicated time in FIG. 7D spans a range of 165 to167 seconds after the start of the ablation, although the invention isnot limited to the plateau region occurring within such a time span.

It is noted that, in some embodiments, the sampled intra-cardiacinformation from which the intra-cardiac electrogram 535 a is derivedmay be filtered (e.g., by way of low pass filtering) to change thedisplayed appearance of the intra-cardiac electrogram 535 a. Forexample, FIG. 7E shows a filtered electrogram 535 a-1, which is afrequency-weighted version of the intra-cardiac electrogram 535 a shownin FIG. 7A. In this particular case, a low pass filter was employed toreduce various biphasic components in the biphasic portion 536 a ofintra-cardiac electrogram 535 a. A maximum peak 537-2 (corresponding tomaximum peak 537-1) having an amplitude of approximately 5 millivoltsand occurring approximately 7.8 seconds after the start of the tissueablation is also shown, although, as discussed above, the invention isnot limited to such amplitude and peak timing.

FIG. 7F includes a graph of a distribution 539 of a plurality of datasets derived from intra-cardiac voltage data sampled by an electrode(e.g., 315, 415) over a period of time that includes a plurality ofcardiac cycles, according to some embodiments. In some embodiments, eachof the data sets is derived from the intra-cardiac voltage data (e.g.,intra-cardiac electrogram data, in some embodiments) sampled by theelectrode during a respective one of the plurality of cardiac cycles. Insome embodiments, each of the data sets provides a respective point orgroup of points in the plotted distribution 539. For example, each ofthe data sets may be generated from the electrogram 535 a-1 of FIG. 7E.In this regard, each of the data sets (e.g., data points in FIG. 7F, insome embodiments) may represent a maximum peak-to-peak voltage valuemagnitude (or a maximum minus minimum voltage value) of the electrogram(e.g., 535 a-1) during a respective one of the cardiac cycles (e.g., acardiac cycle defined by one of the groups of P, Q, R, S, and T waves inthe electrocardiogram 523 a). In some embodiments, if negative voltagevalues are present, a minimum value is considered to be the largestnegative value that gives the greatest voltage range when compared witha maximum positive value. It is noted that other embodiments mayalternately employ data sets representative of absolute maximum values(an absolute value of a peak positive or negative value), positive peakvalues, or negative peak values. Each respective one of the data setsmay be plotted as a function of the particular sampling time, during theablation, of the particular data (e.g., sampled during the respectivecardiac cycle) from which the respective one of the data sets wasderived. For example, if a data point in the distribution 539 is derivedfrom a cardiac cycle represented in an intra-cardiac electrogramspanning a particular time period from 10 seconds after ablation to 10.5seconds after ablation, the respective data point in the distributioncould be plotted on the distribution 539 at time 10.25 seconds (or anyother time) within the particular time period, with the same definedtime-plotting convention consistently used for each other data pointwith respect to its own cardiac cycle.

The present inventors have noted that the respective values of the datasets (e.g., as shown in FIG. 7F) increase relatively quickly after thestart of the ablation and reach a maximum peak typically at the point intime at least proximate to the occurrence of maximum peak 537-2 in intracardiac electrogram 535 a-1 in FIG. 7E. As the ablation continues, thepresent inventors have noted that the values of the data sets (e.g.,data points in distribution 539, in some embodiments) fall and thengenerally plateau with relatively little change (e.g., +/−15% or +/−0.3millivolts in some embodiments). During ablation, the peak of a portionof the monophasic intra-cardiac electrogram derived from data sampledduring a particular cardiac cycle, typically corresponds to a pointwhere a propagation of the local atrial depolarization front passes thesampling electrode. This typically occurs within the P wave portion ofthe electrocardiogram or between the P wave and Q wave portions of theelectrocardiogram, which in various embodiments is a consequence of thepropagation of the depolarization front over the whole of the atria ofthe heart. As the ablation continues during successive cardiac cycles,the peak of the respective portion of the monophasic intra-cardiacelectrogram derived from data sampled during each of the successivecardiac cycles decays as a consequence of the continued expansion orgrowth of the ablated area including a growth of the depth of theablated region (e.g., into the tissue wall). In some embodiments, theamplitude of the monophasic waveform contribution is proportional to therange (e.g., maximum minus minimum voltage) of the monophasic waveform.

The inventors have noted that (a) the time from the start of ablation tothe time of the maximum voltage peak (e.g., a maximum peak of arespective decay distribution like maximum peak 537-3 of distribution539 in FIG. 7F or a maximum peak of a respective electrogram likemaximum peak 537-1 of electrogram 535 a or maximum peak 537-2 ofelectrogram 535 a-1, according to some embodiments), and (b) thecurve-slope (e.g., curve-slope 536 f in FIG. 7F, which may be differentin different embodiments) from the time of occurrence of the maximumvoltage peak to a time (e.g., time 536 e in FIG. 7F, which may bedifferent in different embodiments) indicating a beginning of apre-plateau transitional region (e.g., transitional region 536 d in FIG.7F, which may be different in different embodiments, and which maycorrespond to the corresponding times in the electrograms of FIGS.7A-7E, although such times are not shown in those figures) provideindications of the thickness of the tissue being ablated. For example, arelatively short time from the start of ablation to the maximum voltagepeak (e.g., less than 9 seconds), when electrode size andtissue-ablative-energy-transmitted are held constant, will indicatethinner tissue (e.g., less than 2.5 mm) than a relatively longer time(e.g., greater than 9 seconds) from the start of ablation to the maximumvoltage peak which indicates relatively thicker tissue (e.g., greaterthan 2.5 mm). In addition, when electrode size andtissue-ablative-energy-transmitted are held constant, a steepercurve-slope from the maximum voltage peak to the beginning of thepre-plateau transitional region will indicate thinner tissue than arelatively flatter curve-slope from the maximum voltage peak to thebeginning of the pre-plateau transitional region.

For example, FIGS. 10A and 10B provide in-vivo data illustrating thesefeatures. The procedures which generated the data represented in FIGS.10A and 10B employed relatively equal electrode size and relativelyequal tissue-ablative-energy-transmission levels. FIG. 10A represents adecay distribution 1539A like distribution 539 for thin cardiac tissue(e.g., less than 2.5 mm), whereas FIG. 10B represents a decaydistribution 1539B like distribution 539 for thick cardiac tissue (e.g.,greater than 2.5 mm). In this regard, it can be seen in FIG. 10A thatthe time from the start of ablation to the time 1536 gA of the maximumvoltage peak 1537A is approximately 7-8 seconds for the thin tissue,whereas the time from the start of ablation to the time 1536 gB of themaximum voltage peak 1537B in FIG. 10B is approximately 14-15 secondsfor the thick tissue. Further, it can be seen in FIG. 10A that thecurve-slope 1536 fA from a time proximate the time 1536 gA of themaximum voltage peak 1537A to a time 1536 eA indicating a beginning of apre-plateau transitional region in the distribution 1539A is steeper forthe thin tissue than it is for the thick tissue, as shown in FIG. 10B.In particular, the curve-slope 1536 fB from a time proximate the time1536 gB of the maximum voltage peak 1537B to a time 1536 eB indicating abeginning of a pre-plateau transitional region in the distribution 1539Bis less steep than the curve-slope 1536 fA for the thin tissue.

Accordingly, in some embodiments, the data processing device system(e.g.,110, 310) is configured to identify a time of the maximum voltagepeak from the start of ablation, the above-discussed curve-slope, orboth, and based at least on known electrode size, shape, andablation-energy-delivery characteristics, as well as a comparison withpreviously stored or predetermined time-to-peak/curve-slope information(e.g., thresholds) that relate(s) time-to-peak, respective curve-slope,or both to tissue thickness, the data processing device system (e.g.,110, 310) is configured to output an indication via the input-outputdevice system 120 (e.g., via a display device user interface like any ofthose shown in FIG. 5) of tissue thickness proximate the electrode(e.g., 315, 415) that provided the data that resulted in thedistribution curve 539. In addition or in the alternative, the dataprocessing device system (e.g., 110, 310) may be configured to output anindication via the input-output device system 120 (e.g., via a displaydevice user interface like any of those shown in FIG. 5) of an estimateof projected ablation time required for transmurality, as ablation timeis a function of tissue thickness. Such indications may be especiallyhelpful when multiple electrodes are simultaneously performing tissueablation.

In some embodiments, the data processing device system (e.g., 110, 310)is configured, e.g., by data reception instructions to cause receptionof intra-cardiac voltage data via an input-output device system 120, theintra-cardiac voltage data sampled by a sensing electrode (e.g., 315,415) over a period of time that includes a plurality of cardiac cycles.Activation instructions may configure the data processing device system(e.g., 110, 310) to cause an ablation electrode (e.g., 315, 415, same ordifferent than the sensing electrode) to transmit energy sufficient fortissue ablation at least during the sampling of the intra-cardiacvoltage data by the sensing electrode. Data derivation instructions mayconfigure the data processing device system (e.g., 110, 310) to deriveat least a plurality of voltage values (e.g., data points in anelectrogram or decay curve), each of the plurality of voltage valuesderived at least in part from a respective portion of the receivedintra-cardiac voltage data (e.g., some or all of the intra-cardiacvoltage data associated with a particular cardiac cycle). Each of theplurality of voltage values may be correlated, according to thederivation instructions, with a respective time within a time rangeduring which that the respective portion of the of the receivedintra-cardiac voltage data was sampled by the sensing electrode. Forexample, if the voltage values are data points in a decay curve likedistribution 539, each data point is correlated with a time on theX-axis in FIG. 7F, which is a time within a respective cardiac cycle inan electrogram, e.g., 535 a-1, from which such data point was derived.Identification instructions may configure the data processing devicesystem (e.g., 110, 310) to identify a duration from a time from a startof the tissue ablation to the respective time (e.g., time 1536 gA inFIG. 10A) correlated with a particular one of the respective voltagevalues, the particular one of the respective voltage values being amaximum value (e.g., peak 1537A in FIG. 10A) as compared with others ofthe plurality of voltage values. Tissue thickness determinationinstructions may be configured to determine a thickness of tissuesubject to the tissue ablation based at least upon a comparison of theidentified duration with a predetermined threshold. Thickness indicationinstructions may be configured to output a tissue-thickness indicationvia the input-output device system indicating a result of thedetermination of the thickness of the tissue. In some embodiments, theactivation instructions may be configured to cause the ablation to ceasewithin a particular predetermined time after the tissue thicknessdetermination has been made, the particular predetermined time varyingin accordance with the particular thickness of the tissue that isdetermined. In some embodiments, the particular predetermined time ispredetermined to cause the ablation to continue for an additional timesufficient to cause a transmural lesion in tissue having a thicknesscorresponding to the thickness indicated by the tissue thicknessdetermination instructions.

The data derivation instructions may be configured to derive each of atleast three of the plurality of voltage values only from the respectiveportion of the received intra-cardiac voltage data, each respectiveportion from which a respective one of the at least three of theplurality of voltage values is derived representing some, but not all,of the intra-cardiac voltage data sampled by the sensing electrodeduring a respective cardiac cycle (e.g., excluding a respective portion542 in FIG. 9C as described below). Display instructions may configurethe data processing device system (e.g., 110, 310) to display, via theinput-output device system, the plurality of voltage values, which maybe displayed as a distribution (e.g., 539) or an intra-cardiacelectrogram (e.g., 535 a-1 or 535 a). As discussed above, an electrogram(e.g., 535 a-1 or 535 a) may be concurrently displayed with a decaydistribution (e.g., 539), according to the display instructions. In someembodiments, the electrogram has a visual characteristic set that isdistinct from a visual characteristic set of the decay distribution,such as different colors or different locations on the display. In someembodiments, the voltage values are data points in an intra-cardiacelectrogram (e.g., 537) and the identification instructions mayconfigure the data processing device system (e.g., 110, 310) to identifya duration from a time from a start of the tissue ablation to therespective time of a peak voltage value in the electrogram (e.g., 537-1,537-2). Like various embodiments described above, tissue thicknessdetermination instructions may be configured to determine a thickness oftissue subject to the tissue ablation based at least upon a comparisonof the identified duration with a predetermined threshold. Thicknessindication instructions may be configured to output a tissue-thicknessindication via the input-output device system indicating a result of thedetermination of the thickness of the tissue.

The present inventors have also determined that a lesion formed by theablation in the tissue wall will become transmural in some embodimentswhen the data sets (e.g., data points in distribution 539) have valuesthat remain relatively constant (e.g., in the plateau region of thegraph) or the slope of the plateau region remains fairly constant. Thepresent inventors have determined that a lesion formed by the ablationof the tissue wall will become transmural in some embodiments when thedata sets (e.g., which may be data points in distribution 539 in someembodiments) have values that have fallen by a predetermined amount(e.g., 70%) from the peak value indicated in the graph. The presentinventors have determined that a lesion formed by the ablation in thetissue wall may become transmural when an indication of a rate of changeof a trend of the data set values over the ablation period becomes lessthan a particular rate (e.g., 0.025 millivolts/sec in some embodiments,0.010 millivolts/sec in other embodiments, or 0.002 millivolts/sec inyet other embodiments) at a time at least proximate the plateau region.Such a rate of change analysis may be obtained by determining when thesecond derivative of the plotted data sets becomes zero or within apredetermined range of zero (e.g., absolute value less than 0.1, 0.05,0.02, or 0.01).

Accordingly, in some embodiments, ablation termination instructions maycease the tissue ablation in response to an indication of one or moretransmurality determinations made above by the present inventors. Insome embodiments, the data sets are displayed and a user may make atransmurality determination based on the displayed data sets. Forexample, FIG. 6D includes an exploded view of block 602 employedaccording to some embodiments in which at least the derived data setsare displayable (e.g., via a respective electrogram 535 subpanel in oneor more of FIG. 5 via the display instructions associated with block604, according to some embodiments) to a user such as a health careprovider. Block 602 may include reception instructions associated withblock 602-e that cause a reception of intra-cardiac voltage data via aninput-output device system (e.g., 120, 320), the intra-cardiac voltagedata sampled by an electrode (e.g., an electrode 315, 415) over a periodof time that includes a plurality of cardiac cycles, including a firstcardiac cycle and a second cardiac cycle. The instructions associatedwith block 602-e may be configured to cause a data processing devicesystem (e.g., 110, 310) to receive the voltage data as discussed abovewith respect to block 602 in FIG. 6A, but, in some embodimentsassociated with block 602-e, the intra-cardiac information may includevoltage data sampled by an electrode (e.g., an electrode 315, 415) overa period of time that includes a plurality of cardiac cycles, includinga first cardiac cycle and a second cardiac cycle. In some embodiments,block 602 includes data derivation instructions associated with block602-f that cause a derivation, for each respective one of the pluralityof cardiac cycles, a respective one of plurality of data sets, at leastin part from a respective portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles (e.g., generating the distribution 539 from anintra-cardiac electrogram 535 a, according to some embodiments).

In some embodiments, the derived data sets are caused to be concurrentlydisplayed via the input-output device system (e.g., via a respectiveelectrogram 535 subpanel in one or more of FIG. 5 according to displayinstructions associated with block 604). For example, FIGS. 8A, 8B, and8C show changes in a displayed graphical representation (which may bedisplayed in a electrogram 535 subpanel in one or more of FIG. 5) atthree successive times, the graphical representation including aconcurrently displayed first data superset 540 a (which may represent anelectrogram, such as all or a portion of electrogram 535 a in FIG. 7A)and a concurrently displayed second data superset 540 b (which mayrepresent an electrogram decay distribution, such as all or a portion ofdistribution 539). (Note that first data superset 540 a is equivalentlyreferred to as “first data set” 540 a herein, and second data superset540 b is equivalently referred to as “second data set” 540 b herein.) Invarious embodiments, the graphical representation is displayed via aninput-output device system (e.g., 120, 320). In some embodiments, thegraphical representation is displayed via a graphical interface, forexample, the graphical interface shown in various ones of FIG. 5. Insome embodiments, the concurrently displayed first data set 540 aincludes and represents a first graphical distribution of data thatincludes first data (e.g., at least a portion of the data (e.g., a firstgroup of voltage magnitudes) plotted for first data set 540 a) displayedacross a first time scale (represented, e.g., by the lower horizontalx-axis in each of FIG. 8), and the concurrently displayed second dataset 540 b includes and represents a second graphical distribution ofdata that includes second data (e.g., at least a portion of the data(e.g., a second group of voltage magnitudes) plotted for second data set540 b) displayed across a second time scale (represented, e.g., by theupper horizontal x-axis in each of FIG. 8) that is different than thefirst time scale. In some embodiments, the concurrently displayed firstdata set 540 a and the concurrently displayed second data set 540 b aredisplayed concurrently with each other for at least a period of time,such as in a superimposed or overlapping configuration, such as thatillustrated in each of FIGS. 8A-8C. However, the first data set 540 aand second data set 540 b may be concurrently displayed in a separatemanner, e.g., one-above-another in a same graph as shown, e.g., in FIGS.8D-8F, or, e.g., entirely separately on their own respective graphs.

In some embodiments, the concurrently displayed first data set 540 a isrepresented as an electrogram (e.g., intra-cardiac electrogram 535 a).Accordingly, in some embodiments, the concurrently displayed first dataset 540 a and the concurrently displayed second data set 540 b may bedisplayed as a portion of an intra-cardiac electrogram panel displayedas part of a graphical interface (e.g., a subpanel displaying at leastone of the intra-cardiac electrograms 535 shown in the panel ofintra-cardiac electrograms displayed by the graphical representation inFIGS. 5L and 5M). The number of intra-cardiac electrogram pulses orcycles displayed in each of FIGS. 8A, 8B, and 8C (and FIGS. 8D, 8E, and8F described below) corresponds to an electrogram sweep speed ofapproximately 50 millimeters per second and may be changed to differentvalues by user manipulation of various ones of the electrogram sweepspeed buttons 528 shown in FIGS. 5L and 5M by way of non-limitingexample.

In some embodiments, the concurrently displayed second data set 540 bultimately is provided by distribution 539. As described above,distribution 539 includes a plurality of data sets (e.g., data points,as contrasted with first data superset 540 a and second data superset540 b which represent segments or entireties of graphs, according tosome embodiments). Each of the data sets in the distribution 539, asdiscussed above, may be derived from intra-cardiac voltage data sampledby an electrode (e.g., 315, 415) during a respective one of a pluralityof cardiac cycles. In some embodiments, each of the data sets indistribution 539 may be generated from the electrogram 535 a of FIG. 7A.Specifically, in some embodiments, each of the data sets in distribution539 is derived from at least two values in the respective portion of theintra-cardiac voltage data sampled by an electrode (e.g., in accordancewith the computer-executable instructions associated with block 602-e)during a respective one of the plurality of the cardiac cycles. In someembodiments, each of the data sets includes data representative of adifference between two values in the respective portion of theintra-cardiac voltage data sampled by an electrode (e.g., in accordancewith the instructions associated with block 602-e) during a respectiveone of the plurality of the cardiac cycles. In some embodiments, each ofthe data sets represents a maximum peak-to-peak voltage value magnitude(or a maximum minus minimum voltage value) of the electrogram during arespective one of the cardiac cycles, as, e.g., discussed above withrespect to FIG. 7F. In some embodiments, each of the data sets (e.g.,points in distribution 539) represents peak or maximum voltage value ofthe electrogram during a respective one of the cardiac cycles.

As indicated by the sequence of FIGS. 8A, 8B, and 8C in which theconcurrently displayed second set 540 b (distribution 539) grows as thesequence advances, each of the plurality of data sets in distribution539 is sequentially displayed (e.g., as points along the distribution539) by the input-output device system (e.g., in accordance with theinstructions associated with block 604) until all of the plurality ofdata sets are concurrently displayed. In some embodiments, the pluralityof data sets in distribution 539 are sequentially displayed (e.g., inaccordance with the instructions associated with block 604) according toa first order that is consistent with an order of the plurality of thecardiac cycles associated with the plurality of data sets indistribution 539. In some embodiments, the plurality of data sets indistribution 539 are displayed (e.g., in accordance with theinstructions associated with block 604) according to a first spatialorder representative of an order of the plurality of the cardiac cyclesassociated with the plurality of data sets in distribution 539.Specifically, in FIG. 8A, a group of data sets making up a displayedportion of the concurrently displayed second data set 540 b are shownand are derived from data sampled from the particular cardiac cyclesoccurring within the first 9 seconds from the start of the ablation. Insome embodiments, a maximum value of the peak-to-peak values representedby the data set associated with a particular one of the cardiac cyclesis displayed for each of the particular cardiac cycles occurring withinthe first 9 seconds from the start of ablation. For example, in FIG. 8A,the maximum value of the peak-to-peak value for the cardiac cycleoccurring approximately 8 seconds from the start of ablation isapproximately 6 millivolts and is represented as the first data point onthe right-Y-axis in the distribution 539.

FIG. 8A also shows the intra-cardiac electrogram 535 a (e.g., an exampleof concurrently displayed first data set 540 a) as it appears 7 to 9seconds after the start of the tissue ablation (e.g., a series ofmonophasic pulses having amplitudes of approximately 5 millivolts asrepresented by the left-Y-axis). In this regard, FIG. 8A (as well aseach of the others of FIG. 8) shows the intra-cardiac electrogram 535 a(e.g., an example of concurrently displayed first data superset 540 a)concurrently displayed with a plurality of data sets (e.g., data points)of the second data superset 540 b (e.g., at least part of thedistribution 539), the intra-cardiac electrogram 535 a derived from atleast a portion of the respective intra-cardiac voltage data sampled bythe respective electrode.

In FIG. 8B, a group of data sets (e.g., data points including the datapoints shown in FIG. 8A, according to some embodiments) making up adisplayed portion of the concurrently displayed second data superset 540b are shown and are derived from data sampled from the particularcardiac cycles occurring within the first 52 seconds from the start ofthe ablation. In particular, values of the data sets (e.g., data points,in some embodiments) making up the concurrently displayed second dataset 540 b have decayed from the maximum value shown in FIG. 8A and haveapproached or are about to approach a plateau region of the distribution539, which in some embodiments may provide a visible indication that atransmural lesion has been achieved by the tissue ablation process, andthereby allow determination of whether the ablation process should stop.In some embodiments, values of the data sets (e.g., data points, in someembodiments) making up the concurrently displayed second data set 540 bin FIG. 8B have decayed from the maximum value shown in FIG. 8A, e.g., apeak where the second derivative is zero, and have approached or areabout to approach a subsequent region of the distribution 539 in which asecond derivative of the values with respect to time approaches zero,which in some embodiments may provide an indication that a transmurallesion has been achieved by the tissue ablation process, and therebyallow determination of whether the ablation process should stop.

FIG. 8B also shows the intra-cardiac electrogram 535 a (e.g., an exampleof concurrently displayed first data set 540 a) as it appears 50 to 52seconds after the start of the tissue ablation (e.g., a series ofmonophasic pulses having amplitudes of approximately 2 millivolts). Theamplitudes of the monophasic electrogram pulses in FIG. 8B reduce (e.g.,as compared with FIG. 8A) with increased ablation time. In FIG. 8C, agroup of data sets (e.g., data points including the data points shown inFIGS. 8A and 8B, according to some embodiments) making up a displayedportion of the concurrently displayed second data set 540 b are shownand are derived from data sampled from the particular cardiac cyclesoccurring within approximately 180 seconds from the start of theablation. The values of the data sets (e.g., data points, in someembodiments) making up the concurrently displayed second data set 540 bhave decayed into the plateau region which, in some embodiments providesan indication that a transmural lesion was achieved sometime before thistime. FIG. 8C also shows the intra-cardiac electrogram 535 a (e.g., anexample of concurrently displayed first data set 540 a) as it appears176 to 178 seconds after the start of the tissue ablation (e.g., aseries of monophasic pulses having amplitudes of approximately 1.5millivolts). In this regard, FIGS. 8A-8C show concurrent display ofintra-cardiac electrogram 535 a (e.g., an example of concurrentlydisplayed first data set 540 a) and data sets (e.g., data points in someembodiments) of the second data superset 540 b (e.g., at least part ofthe distribution 539). Also in this regard, FIGS. 8B-8C show monophasicintra-cardiac electrogram 535 a reducing in amplitude with eachsequential display of each of at least some of the plurality of the datasets (e.g., data points in some embodiments) of the second data superset540 b (e.g., at least part of the distribution 539).

Although FIGS. 8A-8C (as well as FIGS. 8D-8F, discussed further below)show an electrogram 535 a, which has not been low-pass filtered, alow-pass filtered electrogram (e.g., like electrogram 535 a-1 in FIG.7E) may instead be displayed (e.g., as at least part of one of thesubpanels displaying at least one of the intra-cardiac electrograms 535shown in the panel of intra-cardiac electrograms displayed by thegraphical representation in FIGS. 5L and 5M), even if a non-low-passfiltered version of the electrogram is used to generate the second datasuperset 540 b. However, second data superset 540 b may be derived fromlow-passed filtered intra-cardiac voltage data. In at least someembodiments, a displayed non-low-pass filtered electrogram (e.g.,electrogram 535 a in FIG. 7A) may undergo a biphasic (e.g., portion 536a in FIG. 7A) to monophasic (e.g., portion 536 b in FIG. 7A)transformation during sequential display of the data sets (e.g., datapoints in some embodiments) of the second data superset 540 b (e.g., atleast part of the distribution 539) through the sequence of FIGS. 8A-8C.

In some embodiments, the data processing device system (e.g., 110, 310)may monitor the displayed progression in the generation of the currentlydisplayed second data set 540 b during the ablation process to identifywhen the plateau region in the second data set 540 b occurs, and providean indication or notification to a user that the transmural lesion hasbeen achieved in response to the identification of the plateau region. Adetermination of transmurality may indicate that the ablation processmay be stopped, and thereby reduce the procedure time or reduce patientexposure to further ablation. In some embodiments, the ablationtermination instructions responsive to values of the data sets in theconcurrently displayed second data set 540 b may automatically causetermination of the application of ablative energy when certainconditions indicating possible transmurality in the ablated tissue(e.g., conditions described above) are indicated by the concurrentlydisplayed second data 540 a.

The displaying of the plurality of data sets (e.g., data points, in someembodiments) of the second data superset 540 b (e.g., at least part ofthe distribution 539) among at least a portion of the intra-cardiacelectrogram 535 a in FIGS. 8A, 8B, and 8C allows a user to concurrentlyand easily assess both sets of information throughout the tissueablation. In some embodiments, unlike FIGS. 8A, 8B, and 8C, theconcurrently displayed first data set 540 a and the concurrentlydisplayed second data set 540 b are not displayed in a superimposedconfiguration. In some embodiments, voltage scales for the concurrentlydisplayed first data set 540 a and the concurrently displayed seconddata set 540 b that are different than those shown in FIGS. 8A, 8B, and8C are employed. For example, FIGS. 8D, 8E, and 8F correspond torespective ones of the sequence of data changes in the concurrentlydisplayed first data set 540 a and the concurrently displayed seconddata set 540 b shown in FIGS. 8A, 8B and 8C. In FIGS. 8D, 8E, and 8F,intra-cardiac electrogram 535-1 is representative of a concurrentlydisplayed first data set 540 a-1 and distribution 539 is representativeof a concurrently displayed second data set 540 b-1. A voltage scale forthe concurrently displayed second data set 540 b-1 of FIGS. 8D, 8E and8F is different than a voltage scale for the concurrently displayedsecond data set 540 b of FIGS. 8A, 8B and 8C. It is noted that variousinformation such as X axis or Y axis information (e.g., titleinformation, scale information) may not be displayed in variousembodiments, but is included herein for the convenience of discussion.

As described above, in various embodiments, each of the data sets (e.g.,data points in some embodiments) in the distribution 539 (e.g., anembodiment of a concurrently displayed second data superset 540 b) arederived at least in part from a peak value or maximum value of a portionof the monophasic intra-cardiac electrogram derived from data sampledduring respective one of plurality of the cardiac cycles. Ideally, thisportion typically corresponds (e.g., temporally) to a portion of theintra-cardiac electrogram impacted by the ablation process (e.g., aparticular portion of the intra-cardiac electrogram undergoing areduction in amplitude with increased ablation time). In variousembodiments, this decaying portion of the intra-cardiac electrogramtypically corresponds to the P wave portion of the electrocardiogram orbetween the P wave and Q wave portions of the electrocardiogram.However, also contributing to the observed electrogram waveform is thefar-field signal of the V wave (a consequence of ventriculardepolarization). If the V wave contribution is sufficiently strong, theV wave may be larger in magnitude than the decaying monophasic waveformassociated with an active ablation of the tissue. For example,intra-cardiac electrograms derived from data sampled relatively closerto the mitral valve will typically have relatively stronger V wavecomponents than intra-cardiac electrograms derived from data sampledrelatively farther from the mitral valve and thus typically comprise adominant V wave component. In some embodiments, it may be preferable toconfigure the data processing device system (e.g., 110, 310) to identifythe maximum or peak voltage values associated with the ablation induceddecaying portions of the intra-cardiac electrogram. However, it may berelatively difficult to distinguish between the ablation-induceddecaying portions of the intra-cardiac electrogram and the V wavecontribution when the V wave is especially dominant or pronounced. Thiseffect can be especially prominent when the ablation-induced decayingportion of the intra-cardiac electrogram has decayed to levelssufficient to make a determination that the ablated tissue region hasbecome transmural, but transmurality cannot be identified because theselevels are lower in magnitude than the V wave amplitude. In the extreme,an erroneous indication of transmurality may be arrived at (e.g., afalse indication of transmurality) when V wave data is mistakenlyemployed.

For example, FIGS. 9A, 9B, and 9C show respective portions of alow-pass-filtered monophasic intra-cardiac electrogram 535 b derivedfrom intra-cardiac voltage data sampled by a particular electrode (e.g.,an electrode 315, 415) over each of three different time periods afterthe start of ablation of cardiac tissue. In some embodiments, thesensing or sampling electrode also transmits the tissue ablative energyduring each of at least the plurality of cardiac cycles represented inthe respective FIGS. 9A-9C. In FIG. 9A, intra-cardiac voltage data issampled during a time period of 5.5 seconds to 7.5 seconds after thestart of ablation. In FIG. 9B, intra-cardiac voltage data is sampledduring a time period of 28 seconds to 30 seconds after the start ofablation. In FIG. 9C, intra-cardiac voltage data is sampled during atime period of 58 seconds to 60 seconds after the start of ablation. Arespective peak 537 b marks a peak or maximum value of each respectivecardiac cycle (e.g., a respective ablation-decay portion of theintra-cardiac electrogram 537 b), a value of each successive peak 537 bmodulating (e.g., growing and decaying) as the ablation progresses in amanner the same as or similar to that described above. In someembodiments, each peak 537 b corresponds to a region between the P waveand Q wave of the electrocardiogram 523 b. It is noted that the V wavesin FIGS. 9A, 9B, and 9C decay slowly throughout the ablation and remainat levels plateauing around 2 millivolts throughout the ablation. Aswill be apparent to those skilled in the art, the data processing devicesystem (e.g., 110, 310) may be configured to identify a maximum or peakvalue associated with the ablation-decaying portion of each cardiaccycle in the intra-cardiac electrogram (e.g., portions comprising peak537 b). However, if precautions are not taken, such maximum or peakvalue may be incorrectly identified as a value associated with the Vwave portion of the intra-cardiac electrogram, which typically decays ata much slower rate than the decaying portion of the intra-cardiacelectrogram when the V wave portion is especially prominent or dominant(for example, as in the illustrated example embodiments). This situationcan subsequently lead to an erroneous determination of ablated tissuetransmurality. It is noted in FIG. 9C that various ones of the peaks 537b have reduced in amplitude during the ablation while correspondingrespective ones of the V waves have greater amplitudes.

Precautions that avoid such erroneous identification of the maximum orpeak value associated with the ablation-decaying portion of each cardiaccycle in the intra-cardiac electrogram (e.g., portions comprising peak537 b) may include excluding the V wave portion in each cardiac cycle ofthe electrogram in the determination of such maximum or peak value. Forinstance, FIG. 6E shows an exploded view of the computer-executable dataderivation instructions associated with block 602-f (i.e., provided inFIG. 6D) employed according to some embodiments. The data derivationinstructions associated with block 602-f may cause a derivation, foreach respective one of the plurality of cardiac cycles, of a respectiveone of a plurality of data sets (e.g., data points in distribution 539or 539 a, according to some embodiments), at least in part from arespective portion of the intra-cardiac voltage data sampled by theelectrode during the respective one of the plurality of cardiac cycles.In various embodiments, the derived data sets (e.g., forming at leastpart of the distribution 539 or 539 a, according to some embodiments)are caused to be displayed via the input-output device system (e.g., bydisplay instructions associated with block 604). Excludable dataidentification instructions may be associated with block 602-g, theexcludable data identification instructions configured to causeidentification, for each respective one the plurality of cardiac cycles,of a particular portion (e.g., a V wave portion, according to someembodiments) of the intra-cardiac voltage data sampled (e.g., by anelectrode 315, 415) during the respective one of the cardiac cycles asan excludable portion of the intra-cardiac voltage data sampled duringthe respective one of the plurality of cardiac cycles. In variousembodiments, each of identified excludable portions of the intra-cardiacvoltage data includes some, but not all, of the intra-cardiac voltagedata sampled during the respective one of the plurality of cardiaccycles. Instructions associated with block 602-h include data derivationinstructions configured to derive, for each respective one of aplurality of cardiac cycles, a respective one of a plurality of datasets (e.g., data points in distribution 539 or 539 a, according to someembodiments) at least in part from a portion of the intra-cardiacvoltage data sampled during the respective one of the plurality ofcardiac cycles, each respective one of the plurality of data setsderived only from particular data that excludes the identified (e.g.,via the computer-executable instructions associated with block 602-g)excludable portion (e.g., the V wave portion, according to someembodiments) of the intra-cardiac voltage data during the respective oneof the plurality of cardiac cycles.

For example, in each of FIGS. 9A, 9B, and 9C, particular portions of thesampled portions the intra-cardiac voltage data corresponding to arespective one of portions 542 of the intra-cardiac electrogram 535 bmay be identified via the instructions associated with block 602-g ascorresponding to or be excludable portions of the sampled intra-cardiacvoltage data. In some embodiments, each excludable portion includes somebut not all of the intra-cardiac voltage data sampled during arespective one of the plurality of cardiac cycles. In some embodiments,each excludable portion excludes a portion of the intra-cardiac voltagedata corresponding to the particular V wave of the intra-cardiacelectrogram 535 b portion corresponding to the respective cardiac cycle.Accordingly, in some of these particular embodiments, excluding theexcludable portions of the sampled intra-cardiac voltage data allows forderivation of the each of the data sets based at least on a maximum orpeak value of a relevant ablation-induced decaying portion (e.g.,represented by an electrogram portion comprising a peak 537 b) of thesampled intra-cardiac voltage data, while eliminating the risk that amaximum or peak value of a non-ablation-induced decaying portion (e.g.,a V wave portion) is instead identified. In some embodiments, excludingintra-cardiac voltage data from when the V wave is present permits theablation-driven decay of the monophasic amplitude to be accuratelyreflected and allows, in some embodiments, a more accurate transmuralitydetermination.

Various excludable portions of the sampled intra-cardiac voltage datamay be identified in different manners according to various embodiments.For example, FIG. 6F shows some implementation details of variousembodiments of method 600 according to some embodiments. In this regard,blocks 616 and 618 may be located, in some embodiments, immediatelybefore block 602-g in block 602-f in FIG. 6E. In particular, block 616may be associated with cardiac event identification instructionsconfigured to cause a data processing device system (e.g., 110, 310) toidentify a respective occurrence of a particular cardiac event in eachof the plurality of cardiac cycles, e.g., from the intra-cardiac voltagedata sampled by the respective electrode. Block 618 is associated withdata identification instructions configured to identify a respectiveexcludable first portion of the intra-cardiac voltage data identified inaccordance with a predetermined temporal relationship with therespective occurrence of the particular cardiac event identified in therespective one of the plurality of cardiac cycles. In some embodiments,the excludable data identification instructions associated with block602-g (i.e., FIG. 6E) are configured to identify each excludable portionof the intra-cardiac voltage data sampled during the respective one ofthe plurality of cardiac cycles as being or at least including theidentified respective excludable first portion (i.e., identified via thecomputer-executable instructions associated with block 618) occurring inthe respective one of the plurality of cardiac cycles. For instance, anexcludable portion (e.g., a V wave portion) within a cardiac cycle of anintra-cardiac electrogram may be identified according to theinstructions associated with block 618 as being or at least including afirst portion of the corresponding intra-cardiac voltage data sampled bythe respective electrode, the first portion having a predeterminedtemporal relationship with a respective occurrence of a particular eventwithin the cardiac cycle identified according to the instructionsassociated with block 618. An example of the cardiac event, as describedin more detail below, may be an R wave in an electrocardiogram, or someother cardiac event, such that the V wave portion has a predeterminedtemporal relationship (e.g., occurs contemporaneously) with the R waveor other cardiac event, according to some embodiments. The dataderivation instructions (i.e., associated with block 602-h) may beconfigured according to various embodiments to derive, for eachrespective one of the plurality of cardiac cycles, a respective one ofthe plurality of data sets at least in part from a respective secondportion of the sampled intra-cardiac voltage data during the respectiveone of the plurality of cardiac cycles, each respective one of theplurality of data sets derived only from particular data (which may beor at least include the second portion of the sampled intra-cardiacvoltage data, according to some embodiments) that excludes theexcludable portion of the intra-cardiac voltage data identified in therespective one of the plurality of cardiac cycles, each excludableportion including the respective first portion (i.e., identified via thecomputer-executable instructions associated with block 618) identifiedin the respective one of the plurality of cardiac cycles.

In some embodiments, the cardiac event identificationcomputer-executable instructions associated with block 616 areconfigured to identify the respective occurrence of the particularcardiac event in each respective one of the plurality of cardiac cyclesfrom data other than the sampled intra-cardiac voltage data (e.g., dataother than the sampled intra-cardiac voltage data employed to generateintra-cardiac electrogram 535 b in FIGS. 9A, 9B, and 9C). For example,in some embodiments, the respective occurrence of the particular cardiacevent in each of the respective one of the plurality of cardiac cyclesis identified from electrocardiogram data. For example, the particular Rwave in each particular cardiac cycle in electrocardiogram 523 b inFIGS. 9A, 9B, and 9C may be identified as the particular cardiac event,because it is typically readily identifiable as it comprises a maximummagnitude or amplitude (e.g., a maximum absolute voltage value in theelectrocardiogram data 523 b) as compared to the respective peak valuesof the respective other waves associated with the particular cardiaccycle in the electrocardiogram 523 b (i.e., each particular R wave hasthe greatest peak value as compared to the peak values of the otherwaves which combined with the particular R wave make up a respective oneof the cardiac cycles). In some embodiments, the data processing devicesystem (e.g., 110, 310) is configured to identify or locate each of theR waves. For example, a threshold sufficiently above typical P wave, Qwave, S wave, and T wave peak values may be set, and an average ormedian value of the corresponding times of the portions of theelectrocardiogram data above the threshold may be employed to determinethe location of each R wave in its respective cardiac cycle.

In various embodiments, a particular time associated with the occurrenceof each of the R waves (e.g., a time corresponding to the peak of theidentified R wave) is identified. In some embodiments, each excludableportion of the sampled intra-cardiac portion of the intra-cardiac datais determined in accordance with a predetermined temporal relationshipwith a respective identified times. For example, in FIGS. 9A, 9B, and9C, each portion 542 of intra-cardiac electrogram 535 b corresponds tothe identified particular time of a respective one of the R waves. Inthese particular illustrated embodiments, a bilateral time interval isdetermined for each identified particular time of a respective one ofthe R waves, the bilateral time interval defining extents of eachportion 542 of intra-cardiac electrogram 535 b. In these particularillustrated embodiments, each time interval is a predetermined timeinterval that includes the identified particular time of a respectiveone of the R waves. In various embodiments, portions of theintra-cardiac voltage data sampled during each of the time intervals areidentified as excludable portions and are excluded from thedetermination of the data sets.

In various embodiments, the bilateral time interval comprises an equaltime interval on each side of the identified particular time associatedwith the occurrence of the R wave as the particular cardiac event, whilein other embodiments the bilateral time interval comprises an unequaltime interval on each side of the identified particular time. In someembodiments, a unilateral time interval is determined in which theidentified particular time forms a beginning or end thereof. In someparticular embodiments, each of the portions 542 has been selectedsufficiently large to allow for the exclusion of intra-cardiac voltagedata corresponding to a respective one of the V waves in theintra-cardiac electrogram data. In some embodiments, each of theportions 542 has been selected sufficiently large to allow for theexclusion of intra-cardiac voltage data corresponding to a respectiveone of the V waves in the intra-cardiac electrogram data withoutincluding portions of the intra-cardiac electrogram 535 b that include arespective one of peaks 537 b.

It is noted that various ones of the portions 542 may be defined fromother forms of time intervals in other embodiments. For example, a groupof time intervals, each spanning different amounts of time, may beemployed in some embodiments. In some embodiments, a unilateral timeinterval is defined for each of at least some of the identifiedparticular cardiac events. In various embodiments, the dataidentification instructions associated with block 618 are configured toidentify each respective first portion (which may represent all or aportion of the excludable portion, e.g., 542) of the sampledintra-cardiac data as including a portion of the intra-cardiac voltagedata sampled at least in part during the occurrence of the particularcardiac event identified in the respective one of the plurality ofcardiac cycles (for example, as shown in FIGS. 9A, 9B, and 9C). Invarious embodiments, the data identification instructions associatedwith block 618 are configured to identify each respective first portion(which may represent all or a portion of the excludable portion, e.g.,542) of the sampled intra-cardiac data as including a portion of theintra-cardiac voltage data sampled at least in part after the occurrenceof the particular cardiac event identified in the respective one of theplurality of cardiac cycles. In various embodiments, the dataidentification instructions associated with block 618 are configured toidentify each respective first portion (which may represent all or aportion of the excludable portion, e.g., 542) of the sampledintra-cardiac data as including a portion of the intra-cardiac voltagedata sampled at least in part before the occurrence of the particularcardiac event identified in the respective one of the plurality ofcardiac cycles. In some embodiments, the data identificationinstructions associated with block 618 are configured to identify eachrespective first portion (which may represent all or a portion of theexcludable portion, e.g., 542) of the sampled intra-cardiac data as notincluding any portion of the intra-cardiac voltage data sampled during atime of the occurrence of the particular cardiac event identified in therespective one of the plurality of cardiac cycles.

In some embodiments, the particular cardiac event may be identified fromthe particular intra-cardiac electrogram that corresponds to the sampledintra-cardiac voltage data or from another intra-cardiac electrogram(for example another intra-cardiac electrogram derived fromintra-cardiac voltage data sampled by a second electrode). In variousembodiments, multiple intra-cardiac electrograms are concurrentlydisplayed (e.g., FIGS. 5L and 5M). In some of these various embodiments,each of the electrograms is derived from voltage data sampled by arespective one of a plurality of electrodes (e.g., electrodes 315, 415).The plurality of electrodes may sample the voltage data concurrently insome embodiments. In some embodiments, at least one particular one ofthe intra-cardiac electrograms may have a particular pronounced portionrepresentative of a particular cardiac event that is present in each ofthe plurality of cardiac cycles (e.g., a pronounced V wave portion). Theat least one particular one of the intra-cardiac electrograms may beused as a basis for the determination of the excludable portions inother ones of the intra-cardiac electrograms (for example, in a mannersimilar to the electrocardiogram methods described above).

The V wave in intra-cardiac electrograms or the R wave inelectrocardiograms is typically associated with ventricular systole. Insome embodiments, the particular cardiac event is not identified fromelectrocardiograms or electrograms, but rather from transducer datarepresentative of blood pressure data. For example, in some embodiments,the cardiac event identification instructions associated with block 616are configured to identify from blood pressure data the respectiveoccurrence of the particular cardiac event in each respective one of theplurality of cardiac cycles as a respective occurrence of ventricularsystole during the respective one of the plurality of cardiac cycles.

It is noted that in some embodiments, the particular cardiac eventidentified by the cardiac event instructions associated with block 616is not limited to events associated with ventricular systole (e.g., an Rwave or V wave). Without limitation, other particular cardiac eventsthat may occur or repeat in each of the plurality of cardiac cycles andwhich are sufficiently detectable such that a first portion (which mayrepresent all or a portion of the excludable portion, e.g., 542) of thesampled intra-cardiac voltage data sampled during a respective one ofthe cardiac cycles can be identified in accordance with a predeterminedtemporal relationship with the particular cardiac event identified inthe respective one of the cardiac cycles may be employed by someembodiments. Without limitation, the cardiac event identificationinstructions associated with block 616 may be configured, in someembodiments, to identify the respective occurrence of the particularcardiac event in each respective one of a plurality of cardiac cycles asa respective occurrence of at least part of a QRS complex inelectrocardiogram data during the respective one of the cardiac cycles,a respective occurrence of P wave in electrocardiogram data during therespective one of the cardiac cycles, or a respective occurrence of Twave in electrocardiogram data during the respective one of the cardiaccycles. Without limitation, the cardiac event identificationinstructions associated with block 616 may be configured, in someembodiments, to identify the respective occurrence of the particularcardiac event in each respective one of the plurality of cardiac cyclesas a respective occurrence of ventricular systole during the respectiveone of the cardiac cycles, a respective occurrence of ventriculardiastole during the respective one of the cardiac cycles, a respectiveoccurrence of atrial systole during the respective one of the cardiaccycles or a respective occurrence of atrial diastole during therespective one of the cardiac cycles.

In some embodiments, the excludable data identification instructionsassociated with block 602-g are configured to identify the excludableportion of the intra-cardiac voltage data sampled during a respectiveone of the plurality of cardiac cycles as a first portion (which mayrepresent all or a portion of the excludable portion, e.g., 542) of theintra-cardiac voltage data sampled during the respective one of theplurality of cardiac cycles, the first portion being identified asincluding a peak value, a maximum value or maximum absolute value of theintra-cardiac voltage data sampled during the respective one of theplurality of cardiac cycles. In some embodiments, each identified firstportion (which may represent all or a portion of the excludable portion,e.g., 542) of the intra-cardiac voltage data includes some but not allof the intra-cardiac voltage data sampled during the respective one ofthe plurality of cardiac cycles. In some embodiments, each of thesefirst portions is identified as part of, or in response to, theidentification of a particular cardiac event (for example, as per theinstructions associated with block 616 and 618) in a respective one of aplurality of cardiac cycles. In some embodiments, a particular cardiacevent is not necessarily identified as a precursor to the identificationof at least some of the first portion which may include a peak value, amaximum value, or maximum absolute value of the intra-cardiac voltagedata sampled during the respective one of the plurality of cardiaccycles. For example, intra-cardiac voltage data sampled by an electrode(e.g., 315, 415) at a position proximal to a mitral valve typically willinclude a V wave portion that includes a peak or maximum value ascompared with the rest of the intra-cardiac voltage data sampled by theelectrode during a particular one of the cardiac cycles (for example, asshown in FIG. 9C). Accordingly in these particular embodiments, aportion of the intra-cardiac voltage value including a peak value, amaximum value, or maximum absolute value of the intra-cardiac voltagedata sampled during a respective one of the plurality of cardiac cyclesmay be directly identified as an excludable portion of the intra-cardiacvoltage data sampled during the respective one of the plurality ofcardiac cycles.

FIG. 9D shows a group of concurrently displayed data sets similar tothose shown in FIG. 8C, the concurrently displayed data sets displayedin accordance with various display instructions (e.g., the displayinstructions associated with block 604). In some embodiments, theconcurrently displayed data sets are shown and are derived from datasampled from particular cardiac cycles occurring within approximately 60seconds from the start of the ablation, and are derived in particularfrom the intra-cardiac voltage data associated with various ones ofFIGS. 9A, 9B, and 9C. The concurrently displayed data sets (which may bevoltage magnitude sets and may be frequency-weighted, as discussedabove) include a concurrently displayed first data set (or superset) 540c and a concurrently displayed second data set (or superset) 540 d. Insome embodiments, both the concurrently displayed first data set 540 cand the concurrently displayed second data set 540 d are concurrentlydisplayed. In some embodiments, the first data set 540 c includesintra-cardiac electrogram 535 b and, in particular, displays arepresentation of the sampled intra-cardiac voltage sampled across aplurality of cardiac cycles during a period of time between 58 and 60seconds after the start of ablation. In some embodiments, the seconddata set 540 d includes a distribution 539 a of data sets (e.g., plottedpoints along distribution 539 a), each of the data sets derived from atleast some of the intra-cardiac voltage data sampled across a pluralityof cardiac cycles during a period of time between a time just after thatstart of ablation and a time of approximately 60 seconds after the startof ablation. In some embodiments, each data set in the second datasuperset 540 d is a respective one of a plurality of voltage magnitudesets. In some embodiments, and in a manner similar to variousembodiments described above, each of the data sets in the second datasuperset 540 d include data representative of a difference between twovalues (e.g., a difference between a maximum value and a minimum value(e.g., a maximum peak-to peak value)) of at least some of theintra-cardiac voltage data sampled during a respective one of theplurality of cardiac cycles, the difference being calculated from asampling time excluding the excludable portion 542 in the respective oneof the plurality of cardiac cycles, according to some embodiments. Insome embodiments, other forms of data sets may be provided by the seconddata superset 540 d. For example, each of the data sets in the seconddata set 540 d may include data representative of a maximum value of atleast some of the intra-cardiac voltage data sampled during a respectiveone of the plurality of cardiac cycles (e.g., excluding the respectiveexcludable portion 542, according to some embodiments). In someembodiments, each of the data sets in the second data set 540 d includesa voltage magnitude set that is frequency-weighted, e.g., as discussedabove with respect to FIG. 7E.

In some embodiments, as shown in FIG. 9D, the concurrently displayeddata sets in the second data set (or superset) 540 d are displayed amongat least a portion of the intra-cardiac electrogram 535 b (e.g.,concurrently displayed data sets of the first data set (or superset) 540c). In some embodiments according to FIG. 9D, the concurrently displayeddata sets in the second data set 540 d are displayed in an overlappingor superimposed configuration with at least part of the intra-cardiacelectrogram 535 b (e.g., which represents concurrently displayed datasets of the first data set 540 c). In some embodiments according to FIG.9D, the activation instructions associated with block 614 are configuredto cause the electrode (e.g., 315, 415) that samples the intra-cardiacvoltage data to also transmit energy sufficient for tissue ablation atleast during the sampling of the intra-cardiac voltage data by theelectrode during each of the plurality of cardiac cycles.

In some embodiments according to FIG. 9D, each of the data sets (e.g.,data points) in the distribution 539 a is derived via thecomputer-executable instructions associated with block 602-h and, inparticular, in accordance with blocks 616 and 618. That is, each of thedata sets in the second data set 540 d is derived only from particulardata that excludes an identified excludable potion (e.g., 542) of theintra-cardiac voltage data sampled during a respective one of theplurality of cardiac cycles.

In some embodiments according to FIG. 9D, the first data set 540 cincludes data derived from a respective portion of the intra-cardiacvoltage data sampled by the electrode during each respective one of theplurality of cardiac cycles, each respective portion including at leastsome of the intra-cardiac voltage data that is excluded (e.g., formspart of an excludable portion) in the derivation of a particular dataset in the second data set 540 d derived from the intra-cardiac voltagedata sampled during the respective one of the cardiac cycles. Forexample, the first set data 540 c (e.g., intra-cardiac electrogram 535b) may be derived in accordance with various derivation instructions atleast in part from intra-cardiac voltage data sampled during a pluralityof times in a first cardiac cycle of the plurality of cardiac cycles,the plurality of times including at least a first time in the firstcardiac cycle and a second time in the first cardiac cycle occurringafter the first time in the first cardiac cycle. For example, FIG. 9Cincludes a representation of the intra-cardiac electrogram 535 bassociated with a period of time spanning 58-60 seconds from the startof ablation. An includable first portion 543 a of the electrogram 535 bis derived from intra-cardiac voltage data sampled during a first timein a first cardiac cycle (e.g., a first cardiac cycle represented by therespective portions in the electrocardiogram 523 b indicated as P1, Q1,R1, S1 and T1) and a second portion 542 a derived from intra-cardiacvoltage data sampled during a second time in the first cardiac cycle.However, each of the data sets (e.g., voltage magnitude sets) in thesecond data set (or superset) 540 d have been derived in someembodiments from particular data that excludes an excludable portion(e.g., a portion 542) of the intra-cardiac voltage data sample during arespective one of the cardiac cycles. In some embodiments, portion 542 ais a member of, or forms part of, at least a portion 542, and while usedin the derivation of at least part of the first data set 540 c, does notform part of the particular data from which the second data set 540 d isonly derived from. In some embodiments according to FIG. 9D, the firstdata set 540 c is represented as a first graphical distribution of data,and the second data set 540 d (e.g., distribution 539 a, likedistribution 539) is represented as a second graphical distribution ofdata. The second graphical distribution of data may be derived only fromparticular data excluding respective portions (or particular parts) 542,each portion (or part) 542 including some, but not all, intra-cardiacvoltage data sampled by the electrode during the respective cycle. Thefirst graphical distribution (e.g., first data set 540 c or electrogram535 b) may be derived from data that includes the respective portions(particular parts) 542. In some embodiments according to FIG. 9D, thesecond data set 540 d is derived only from particular data that excludesat least some of the intra-cardiac voltage data sampled during thesecond time (e.g., portion 542 a) in the first cardiac cycle, but alsoincludes at least some of the intra-cardiac voltage data sampled by anelectrode (e.g., 315, 415) during the first time in the first cardiaccycle and sampled by the electrode during a second cardiac cycle (e.g.,a second cardiac cycle represented by the respective portions in theelectrocardiogram 523 b indicated as P2, Q2, R2, S2 and T2 in FIG. 9C).In some embodiments, transmission to the electrode of energy sufficientfor tissue ablation occurs during the first and second cardiac cycles.In some embodiments according to FIG. 9D, the particular data from whichthe second data set 540 d is derived excludes at least a portion of theintra-cardiac voltage data sampled during an occurrence of ventricularsystole in the first cardiac cycle. In some embodiments, the particulardata from which the second data set 540 d is derived excludes a maximumabsolute value of the intra-cardiac voltage data sampled during thefirst cardiac cycle. For example, with reference to FIG. 9C, theexcluded portion 542 a includes a portion of the V wave, the V wavehaving a peak value or maximum absolute value as compared to othervalues of the intra-cardiac electrogram 535 associated with thisparticular cardiac cycle (e.g., the first cardiac cycle).

In various embodiments, the concurrently displayed second data set 540 dincludes data derived from (a) a minimum value of the intra-cardiacvoltage data sampled during the first time in the first cardiac cycle;(b) a maximum value of the cardiac voltage date sampled during the firsttime in the first cardiac cycle; or both (a) and (b). In someembodiments, the concurrently displayed second data set includes dataderived at least in part from a mean value of the cardiac voltage datasampled during the first time in the first cardiac cycle. It is noted invarious embodiments, that the first time in the first cardiac cycle canbe any time (e.g., a continuous or discontinuous time interval) in thefirst cardiac cycle other than the second time. In this regard, in someembodiments, each respective one of the plurality of data sets isderived at least in part from at least one respective part of a portion,other than the excludable portion 542 (e.g., 542 a), of theintra-cardiac voltage data sampled by an electrode (e.g., 315, 415)during a respective one of the plurality of cardiac cycles. The at leastone respective part may include a first respective part including aminimum value, a second respective part including a maximum value, orboth the first respective part and the second respective part, theminimum value and the maximum value being compared with other parts ofthe respective portion (which excludes the respective excludable portion542, in some embodiments) of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles. In this regard, the at least one respective part may include amaximum absolute value in the respective one of the respective portion(which excludes the respective excludable portion 542, in someembodiments) of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles.

In this particular illustrated embodiment, the concurrently displayedsecond set 540 d includes first data representative of a differencebetween two voltage values (e.g., a difference between a maximum valueand a minimum value) of the intra-cardiac voltage data sampled duringthe first cardiac cycle (e.g., excluding the respective excludableportion 542, in some embodiments), and second data representative of adifference between two voltage values (e.g., a difference between amaximum value and a minimum value) of the intra-cardiac voltage datasampled during the second cardiac cycle (e.g., excluding the respectiveexcludable portion 542, in some embodiments). For example, each of theplurality of data sets (e.g., data points, in some embodiments) in thesecond data set 540 d may include data representative of a differencebetween a maximum value and a minimum value in the respective portion(which may exclude the respective excludable portion 542) of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles. In some embodiments,the concurrently displayed second data set 540 d includes datarepresentative of a peak value or a maximum absolute value of theintra-cardiac voltage values sampled during the first time in the firstcardiac cycle.

In various embodiments associated with FIG. 9D, the concurrentlydisplayed first data set 540 c (e.g., forming some or all ofintra-cardiac electrogram 535 b) may be derived at least in part, notonly from at least part of the intra-cardiac voltage sampled by anelectrode (e.g., 315, 415) during a first cardiac cycle, but also from asecond cardiac cycle. For example, the intra-cardiac electrogram 535 bmay be derived from intra-cardiac voltage data sampled by an electrodeover multiple consecutive cardiac cycles. In some embodiments, the firstdata set 540 c may be derived from a particular portion of theintra-cardiac voltage sampled by the electrode during the second cardiaccycle, while this particular portion (e.g., an excludable portion 542)may be excluded from derivation of the second data set 540 d in thissecond cardiac cycle.

In FIG. 9D, the displayed intra-cardiac electrogram 535 b is or includesat least a portion of a monophasic intra-cardiac electrogram in whicheach portion thereof that corresponds to a respective one of the cardiaccycles is represented by a monophasic waveform (e.g., as discussed abovewith respect to monophasic portion 536 b). In particular, in FIG. 9D,the displayed portion of the intra-cardiac electrogram 535 b includes afirst monophasic portion of a part or portion of the intra-cardiacelectrogram derived from at least some of the intra-cardiac voltage datasampled during the first cardiac cycle and a second monophasic portionof a part or portion of the other intra-cardiac electrogram 535 bderived from at least part of the intra-cardiac voltage data sampledduring the second cardiac cycle. Electrocardiogram 523 b is alsoincluded in FIG. 9D.

It is noted that, in like embodiments associated with FIGS. 8A, 8B, and8C and embodiments associated with FIGS. 8D, 8E, and 8F, the variousdisplay instructions (e.g., display instructions associated with block604) may be configured to concurrently display the second data set 540 dat least by displaying (a) the data included in the second data set 540d and derived at least in part from the at least some of theintra-cardiac voltage data sampled during the second cardiac cyclesequentially after (b) the data included in the second data set 540 dand derived at least in part from the intra-cardiac voltage data sampledduring the first time in the first cardiac cycle while continuing todisplay (b) to cause both (a) and (b) to be concurrently displayed. Inthis regard, it is noted, that the first and second data sets 540 c, 540d shown in FIG. 9D may undergo similar transformations as describedabove in the various embodiments with FIGS. 8A, 8B, and 8C andembodiments associated with FIGS. 8D, 8E, and 8F during various timeintervals occurring during the ablation before the 58 second markassociated with FIG. 9D or during various time intervals occurringduring the ablation after the 60 second mark associated with FIG. 9D.

Accordingly, in various embodiments, although FIGS. 9A-9D showelectrogram 535 b, which has been low-pass filtered pursuant to thediscussions above with regard to FIG. 7E, a non-low-pass filteredelectrogram (e.g., akin to electrogram 535 a in FIG. 7A) may instead bedisplayed (e.g., as at least part of one of the subpanels displaying atleast one of the intra-cardiac electrograms 535 shown in the panel ofintra-cardiac electrograms displayed by the graphical representation inFIGS. 5L and 5M), even if a low-pass filtered version of the electrogramis used to generate the second data superset 540 d. In at least some ofsuch embodiments, the displayed non-low-pass filtered electrogram (e.g.,akin to electrogram 535 a FIG. 7A) may undergo a biphasic (e.g., portion536 a in FIG. 7A) to monophasic (e.g., portion 536 b in FIG. 7A)transformation during sequential display (e.g., displayed revealing) ofthe data sets (e.g., data points in some embodiments) of the second datasuperset 540 d (e.g., at least part of the distribution 539 a) over time(assuming that electrogram 535 b is replaced with an electrogram akin to535 a in some embodiments). Similarly, in at least some of suchembodiments, the displayed non-low-pass filtered electrogram (e.g., akinto electrogram 535 a FIG. 7A) may include a first monophasic portionderived from at least some of the intra-cardiac voltage data sampledduring a first cardiac cycle of the plurality of cardiac cycles and asecond monophasic portion derived from at least part of theintra-cardiac voltage data sampled during a second cardiac cycle of theplurality of cardiac cycles (e.g., a second cardiac cycle occurringafter the first cardiac cycle). The first monophasic portion and thesecond monophasic portion may be displayed with an amplitude of thefirst monophasic portion of the displayed portion of the intra-cardiacelectrogram (e.g., akin to electrogram 535 a) being greater than anamplitude of the second monophasic portion of the displayed portion ofthe intra-cardiac electrogram (e.g., akin to electrogram 535 a). Forexample, note the reduction in the amplitude peaks of intra-cardiacelectrogram 535 a between 8 and 11 seconds in FIG. 7A, as discussedabove. Similarly, in at least some of such embodiments, the displayinstructions associated with block 604 may be configured to cause theinput-output device system (e.g., 120, 320) to display a non-low-passfiltered electrogram (e.g., akin to electrogram 535 a FIG. 7A, insteadof low-pass filtered electrogram 535 b in FIG. 9D) as a monophasicintra-cardiac electrogram concurrently with at least the concurrentlydisplayed second data set 540 d. The monophasic intra-cardiacelectrogram may include a plurality of portions, each portion of themonophasic intra-cardiac electrogram corresponding to a respectivecardiac event (e.g., a R wave, V wave or other cardiac event, asdiscussed herein) occurring in a respective one of the plurality ofcardiac cycles, the particular cardiac event being a same cardiac event.In various embodiments, the amplitudes of the particular cardiac eventsrepresented in the monophasic intra-cardiac electrogram by the pluralityof portions, decrease over a time span that includes at least a firstcardiac cycle and a second cardiac cycle. It is noted that in variousembodiments, one or more other cardiac cycles of the plurality ofcardiac cycles may occur between the first and the second cardiaccycles.

In FIG. 9D, the values of the data sets making up the concurrentlydisplayed second data set 540 d decay into a plateau region, which, insome embodiments provides an indication that a transmural lesion wasachieved sometime at or before this time, as discussed above withrespect to FIGS. 7 and 8.

While some of the embodiments disclosed above are described withexamples of cardiac mapping, ablation, or both, the same or similarembodiments may be used for mapping, ablating, or both, other bodilyorgans, for example with respect to the intestines, the bladder, or anybodily organ to which the devices of the present invention may beintroduced.

Subsets or combinations of various embodiments described above canprovide further embodiments.

These and other changes can be made to the invention in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the invention to thespecific embodiments disclosed in the specification and the claims, butshould be construed to include other transducer-based device systemsincluding all medical treatment device systems and all medicaldiagnostic device systems in accordance with the claims. Accordingly,the invention is not limited by the disclosure, but instead its scope isto be determined entirely by the following claims.

What is claimed is:
 1. An intra-cardiac voltage data display systemcomprising: a data processing device system; an input-output devicesystem communicatively connected to the data processing device system;and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system, the program comprising: data receptioninstructions configured to cause reception of intra-cardiac voltage datavia the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time comprising a plurality ofcardiac cycles; data identification instructions configured to identify,for each respective one of the plurality of cardiac cycles, a respectivefirst portion of the intra-cardiac voltage data sampled during therespective one of the plurality of cardiac cycles, each respective firstportion of the intra-cardiac voltage data identified as comprising amaximum absolute value of the intra-cardiac voltage data sampled by theelectrode during the respective one of the plurality of cardiac cycles,each identified first portion of the intra-cardiac voltage datacomprising some but not all of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles; data derivation instructions configured to derive, for eachrespective one of the plurality of cardiac cycles, a respective one of aplurality of data sets at least in part from a respective second portionof the intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each respective oneof the plurality of data sets derived only from particular data thatexcludes the identified first portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles; and display instructions configured to cause theinput-output device system to concurrently display the plurality of datasets.
 2. The intra-cardiac voltage display system of claim 1 wherein thedata derivation instructions are configured to derive each respectiveone of the plurality of data sets at least in part from a firstrespective part of the respective second portion of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles, the first respective part including amaximum value as compared with other parts of the respective secondportion of the intra-cardiac voltage data sampled by the electrodeduring the respective one of the plurality of cardiac cycles.
 3. Theintra-cardiac voltage display system of claim 2 wherein the dataderivation instructions are configured to derive each respective one ofthe plurality of data sets at least in part from a second respectivepart of the respective second portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles, the second respective part including a minimum value ascompared with other parts of the respective second portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles.
 4. The intra-cardiacvoltage display system of claim 1 wherein each of the plurality of datasets comprises data representative of a maximum absolute value in therespective second portion of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles.
 5. The intra-cardiac voltage display system of claim 1 whereineach of the plurality of data sets comprises data representative of adifference between a maximum value and a minimum value in the respectivesecond portion of the intra-cardiac voltage data sampled by theelectrode during the respective one of the plurality of cardiac cycles.6. The intra-cardiac voltage display system of claim 1 wherein each ofthe plurality of data sets comprises data representative of a differencebetween two values in the respective second portion of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles.
 7. The intra-cardiac voltage display systemof claim 1 wherein the program comprises activation instructionsconfigured to cause the electrode to transmit energy sufficient to causetissue ablation at least during the sampling of the intra-cardiacvoltage data by the electrode over the period of time comprising theplurality of cardiac cycles.
 8. The intra-cardiac voltage display systemof claim 1 wherein the display instructions are configured to cause theinput-output device system to sequentially display each of the pluralityof data sets until all of the plurality of data sets are concurrentlydisplayed by the input-output device system.
 9. The intra-cardiacvoltage display system of claim 8 wherein the display instructions areconfigured to cause the input-output device system to sequentiallydisplay each of the plurality of data sets according to a first orderthat is consistent with an order of the plurality of cardiac cyclesduring the period of time.
 10. The intra-cardiac voltage display systemof claim 1 wherein the display instructions are configured to cause theinput-output device system to display the plurality of the data sets ina first spatial order representative of an order of the plurality ofcardiac cycles during the period of time.
 11. The intra-cardiac voltagedisplay system of claim 10 wherein the display instructions areconfigured to cause the input-output device system to sequentiallydisplay each of the plurality of data sets according to a first orderthat is consistent with the order of the plurality of cardiac cyclesduring the period of time.
 12. The intra-cardiac voltage display systemof claim 8 wherein the display instructions are configured to cause theinput-output device system to display an intra-cardiac electrogramconcurrently with the plurality of data sets, the intra-cardiacelectrogram derived from at least a portion of the intra-cardiac voltagedata sampled by the electrode, and the intra-cardiac electrogramundergoing a biphasic to monophasic transformation during at least partof the sequential display of each of the plurality of data sets.
 13. Theintra-cardiac voltage display system of claim 8 wherein the displayinstructions are configured to cause the input-output device system todisplay a monophasic intra-cardiac electrogram concurrently with theplurality of data sets, the monophasic intra-cardiac electrogram derivedfrom at least a portion of the intra-cardiac voltage data sampled by theelectrode, and the monophasic intra-cardiac electrogram reducing inamplitude with each sequential display of each of at least some of theplurality of data sets.
 14. The intra-cardiac voltage display system ofclaim 1 wherein the display instructions are configured to cause theinput-output device system to display an intra-cardiac electrogramconcurrently with the plurality of data sets, the intra-cardiacelectrogram derived from at least a portion of the intra-cardiac voltagedata sampled by the electrode.
 15. The intra-cardiac voltage displaysystem of claim 14 wherein the intra-cardiac electrogram is a monophasicintra-cardiac electrogram.
 16. The intra-cardiac voltage display systemof claim 14 wherein the display instructions are configured to cause theinput-output device system to display the plurality of data sets amongat least a portion of the intra-cardiac electrogram.
 17. Theintra-cardiac voltage display system of claim 1 wherein each of theplurality of data sets comprises a respective one of a plurality ofvoltage magnitude sets.
 18. The intra-cardiac voltage display system ofclaim 17 wherein each respective one of the plurality of voltagemagnitude sets is frequency-weighted.
 19. The intra-cardiac voltagedisplay system of claim 1 wherein each respective second portion of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles comprisesfrequency-weighted data.
 20. The intra-cardiac voltage display system ofclaim 1 wherein the intra-cardiac voltage data is sampled by theelectrode while the electrode is positioned at a same location in anintra-cardiac cavity during each of the plurality of cardiac cycles inthe period of time.
 21. An intra-cardiac voltage data display systemcomprising: a data processing device system; an input-output devicesystem communicatively connected to the data processing device system;and a memory device system communicatively connected to the dataprocessing device system and storing a program executable by the dataprocessing device system, wherein the data processing device system isconfigured by the program at least to: receive intra-cardiac voltagedata via the input-output device system, the intra-cardiac voltage datasampled by an electrode over a period of time comprising a plurality ofcardiac cycles; identify, for each respective one of the plurality ofcardiac cycles, a respective first portion of the intra-cardiac voltagedata sampled during the respective one of the plurality of cardiaccycles, each respective first portion of the intra-cardiac voltage dataidentified as comprising a maximum absolute value of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles, each identified first portion of theintra-cardiac voltage data comprising some but not all of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles; derive, for eachrespective one of the plurality of cardiac cycles, a respective one of aplurality of data sets at least in part from a respective second portionof the intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each respective oneof the plurality of data sets derived only from particular data thatexcludes the identified first portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles; and cause the input-output device system to concurrentlydisplay the plurality of data sets.
 22. An intra-cardiac voltage datadisplay method executed by a data processing device system according toa program stored by a memory device system communicatively connected tothe data processing device system, the data processing device systemfurther communicatively connected to an input-output device system, andthe method comprising: receiving intra-cardiac voltage data via theinput-output device system, the intra-cardiac voltage data sampled by anelectrode over a period of time comprising a plurality of cardiaccycles; identifying, for each respective one of the plurality of cardiaccycles, a respective first portion of the intra-cardiac voltage datasampled during the respective one of the plurality of cardiac cycles,each respective first portion of the intra-cardiac voltage dataidentified as comprising a maximum absolute value of the intra-cardiacvoltage data sampled by the electrode during the respective one of theplurality of cardiac cycles, each identified first portion of theintra-cardiac voltage data comprising some but not all of theintra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles; deriving, for eachrespective one of the plurality of cardiac cycles, a respective one of aplurality of data sets at least in part from a respective second portionof the intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each respective oneof the plurality of data sets derived only from particular data thatexcludes the identified first portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles; and causing the input-output device system toconcurrently display the plurality of data sets.
 23. A computer-readablestorage medium system comprising one or more computer-readable storagemediums storing a program executable by one or more data processingdevices of a data processing device system communicatively connected toan input-output device system, the program comprising: a data receptionmodule configured to cause reception of intra-cardiac voltage data viathe input-output device system, the intra-cardiac voltage data sampledby an electrode over a period of time comprising a plurality of cardiaccycles; a data identification module configured to identify, for eachrespective one of the plurality of cardiac cycles, a respective firstportion of the intra-cardiac voltage data sampled during the respectiveone of the plurality of cardiac cycles, each respective first portion ofthe intra-cardiac voltage data identified as comprising a maximumabsolute value of the intra-cardiac voltage data sampled by theelectrode during the respective one of the plurality of cardiac cycles,each identified first portion of the intra-cardiac voltage datacomprising some but not all of the intra-cardiac voltage data sampled bythe electrode during the respective one of the plurality of cardiaccycles; a data derivation module configured to derive, for eachrespective one of the plurality of cardiac cycles, a respective one of aplurality of data sets at least in part from a respective second portionof the intra-cardiac voltage data sampled by the electrode during therespective one of the plurality of cardiac cycles, each respective oneof the plurality of data sets derived only from particular data thatexcludes the identified first portion of the intra-cardiac voltage datasampled by the electrode during the respective one of the plurality ofcardiac cycles; and a display module configured to cause theinput-output device system to concurrently display the plurality of datasets.